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FDA approves atezolizumab for first-line ES-SCLC treatment
The Food and Drug Administration has approved atezolizumab (Tecentriq), in combination with carboplatin and etoposide, for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
Approval was based on results from the phase 3 IMpower133 study, in which 403 treatment-naive patients with ES-SCLC received atezolizumab at 1,200 mg with carboplatin at 5 mg/mL per minute on day 1 and etoposide 100 mg/m2 on days 1, 2, and 3 of a 21-day cycle for four cycles, followed by atezolizumab at 1,200 mg once every 3 weeks until disease progression or unacceptable toxicity; or received placebo with the same dosage of carboplatin and etoposide for a similar duration.
Overall survival was significantly better in patients who received atezolizumab, compared with placebo (12.3 vs. 10.3 months; hazard ratio, 0.70; 95% confidence interval, 0.54-0.91; P = .0069), as was progression-free survival (5.2 vs. 4.3 months; HR, 0.77; 95% CI, 0.62-0.96; P = .017).
The most common adverse events associated with atezolizumab in the study were fatigue/asthenia, nausea, alopecia, constipation, and decreased appetite.
According to the FDA, the recommended dose is 1,200 mg IV over 60 minutes every 3 weeks. When administered on the same day as chemotherapy, atezolizumab should be given first. If the first infusion is tolerated, all subsequent infusions can be delivered over 30 minutes.
Find the full press release on the FDA website.
The Food and Drug Administration has approved atezolizumab (Tecentriq), in combination with carboplatin and etoposide, for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
Approval was based on results from the phase 3 IMpower133 study, in which 403 treatment-naive patients with ES-SCLC received atezolizumab at 1,200 mg with carboplatin at 5 mg/mL per minute on day 1 and etoposide 100 mg/m2 on days 1, 2, and 3 of a 21-day cycle for four cycles, followed by atezolizumab at 1,200 mg once every 3 weeks until disease progression or unacceptable toxicity; or received placebo with the same dosage of carboplatin and etoposide for a similar duration.
Overall survival was significantly better in patients who received atezolizumab, compared with placebo (12.3 vs. 10.3 months; hazard ratio, 0.70; 95% confidence interval, 0.54-0.91; P = .0069), as was progression-free survival (5.2 vs. 4.3 months; HR, 0.77; 95% CI, 0.62-0.96; P = .017).
The most common adverse events associated with atezolizumab in the study were fatigue/asthenia, nausea, alopecia, constipation, and decreased appetite.
According to the FDA, the recommended dose is 1,200 mg IV over 60 minutes every 3 weeks. When administered on the same day as chemotherapy, atezolizumab should be given first. If the first infusion is tolerated, all subsequent infusions can be delivered over 30 minutes.
Find the full press release on the FDA website.
The Food and Drug Administration has approved atezolizumab (Tecentriq), in combination with carboplatin and etoposide, for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
Approval was based on results from the phase 3 IMpower133 study, in which 403 treatment-naive patients with ES-SCLC received atezolizumab at 1,200 mg with carboplatin at 5 mg/mL per minute on day 1 and etoposide 100 mg/m2 on days 1, 2, and 3 of a 21-day cycle for four cycles, followed by atezolizumab at 1,200 mg once every 3 weeks until disease progression or unacceptable toxicity; or received placebo with the same dosage of carboplatin and etoposide for a similar duration.
Overall survival was significantly better in patients who received atezolizumab, compared with placebo (12.3 vs. 10.3 months; hazard ratio, 0.70; 95% confidence interval, 0.54-0.91; P = .0069), as was progression-free survival (5.2 vs. 4.3 months; HR, 0.77; 95% CI, 0.62-0.96; P = .017).
The most common adverse events associated with atezolizumab in the study were fatigue/asthenia, nausea, alopecia, constipation, and decreased appetite.
According to the FDA, the recommended dose is 1,200 mg IV over 60 minutes every 3 weeks. When administered on the same day as chemotherapy, atezolizumab should be given first. If the first infusion is tolerated, all subsequent infusions can be delivered over 30 minutes.
Find the full press release on the FDA website.
CDC exhorts more testing and treatment of HIV
Approximately 80% of HIV infections in the United States in 2016 were spread by almost 40% of infected individuals who did not know their status or were not receiving care, according to data from the Centers for Disease Control and Prevention.
However, leadership at the Department of Health & Human Services has developed a “bold but completely achievable” plan to reduce HIV infections within the next decade, Vice Adm. Jerome M. Adams, MD, the U.S. surgeon general, said in a teleconference to announce the results of a new Vital Signs report on the impact of undiagnosed and untreated HIV.
In the early release Vital Signs from Morbidity and Mortality Weekly Report, Li Zihao, PhD, and his colleagues at the CDC used a model to estimate rates of HIV transmission in 2016 based on data from the National HIV Behavioral Surveillance on needle-sharing behavior and sexual behaviors. The overall transmission rate was 3.5/100,000 person-years. Of these transmissions, 73.0% were from men who have sex with men, 9.7% from intravenous drug users, and 12% from heterosexuals.
The percentages of transmissions for those who were acutely ill with HIV but unaware, not acutely ill but unaware, aware of HIV infection but not treated, receiving care but not virally suppressed, and receiving care and virally suppressed were 4.0%, 33.6%, 42.6%, 19.8%, and 0%, respectively, the researchers said.
The study “emphasizes the impact that HIV resources could have,” by showing the importance of identifying infected individuals early and using the tools now available to treat them before they can transmit the disease, Jonathan Mermin, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said during the conference.
“Today’s treatment regimens are simpler than those prescribed in the past, sometimes requiring only single-tablet formulations, with fewer side effects; most persons with HIV infection can achieve viral suppression within 6 months of initiating treatment,” the researchers wrote.
In the wake of the findings and at the start of the CDC’s 2019 National HIV Prevention Conference, the CDC proposed a federal initiative, “Ending the HIV Epidemic: A Plan for America.”
The goal is to reduce the incidence of new HIV infections by at least 90% over the next decade, starting with a focus on parts of the country with the highest disease burden, according to the CDC.
“Today’s Vital Signs report illustrates how a goal that once seemed impossible is now within our reach.” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during the conference. “If we increase access to testing and treatment for people with HIV, we could prevent a lion’s share of infections,” he said.
The plan involves working to identify individuals at risk, treating those who test positive as quickly as possible, and keeping them in care. Updated information on the CDC website provides more details for clinicians on how to have conversations about HIV with patients, the latest information about antiretroviral therapy, and details about prevention for partners including post- and pre-exposure prophylaxis (PEP and PreP), and condoms.
Eugene McCray, MD, director of the CDC’s Division of HIV/AIDS Prevention, emphasized that the CDC recommends HIV testing for all individuals aged 13-64 years at least once in their lives. He added that everyone who tests positive should seek medical care, that everyone with HIV deserves support to combat stigma, and that those at risk should be empowered to take advantage of proven effective prevention strategies.
Clinicians can access the updated CDC page on caring for HIV patients here.
SOURCE: Li Z et al. MMWR Morb Mortal Wkly Rep. 2019 March 18. doi: org/10.15585/mmwr.mm6811e1.
Approximately 80% of HIV infections in the United States in 2016 were spread by almost 40% of infected individuals who did not know their status or were not receiving care, according to data from the Centers for Disease Control and Prevention.
However, leadership at the Department of Health & Human Services has developed a “bold but completely achievable” plan to reduce HIV infections within the next decade, Vice Adm. Jerome M. Adams, MD, the U.S. surgeon general, said in a teleconference to announce the results of a new Vital Signs report on the impact of undiagnosed and untreated HIV.
In the early release Vital Signs from Morbidity and Mortality Weekly Report, Li Zihao, PhD, and his colleagues at the CDC used a model to estimate rates of HIV transmission in 2016 based on data from the National HIV Behavioral Surveillance on needle-sharing behavior and sexual behaviors. The overall transmission rate was 3.5/100,000 person-years. Of these transmissions, 73.0% were from men who have sex with men, 9.7% from intravenous drug users, and 12% from heterosexuals.
The percentages of transmissions for those who were acutely ill with HIV but unaware, not acutely ill but unaware, aware of HIV infection but not treated, receiving care but not virally suppressed, and receiving care and virally suppressed were 4.0%, 33.6%, 42.6%, 19.8%, and 0%, respectively, the researchers said.
The study “emphasizes the impact that HIV resources could have,” by showing the importance of identifying infected individuals early and using the tools now available to treat them before they can transmit the disease, Jonathan Mermin, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said during the conference.
“Today’s treatment regimens are simpler than those prescribed in the past, sometimes requiring only single-tablet formulations, with fewer side effects; most persons with HIV infection can achieve viral suppression within 6 months of initiating treatment,” the researchers wrote.
In the wake of the findings and at the start of the CDC’s 2019 National HIV Prevention Conference, the CDC proposed a federal initiative, “Ending the HIV Epidemic: A Plan for America.”
The goal is to reduce the incidence of new HIV infections by at least 90% over the next decade, starting with a focus on parts of the country with the highest disease burden, according to the CDC.
“Today’s Vital Signs report illustrates how a goal that once seemed impossible is now within our reach.” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during the conference. “If we increase access to testing and treatment for people with HIV, we could prevent a lion’s share of infections,” he said.
The plan involves working to identify individuals at risk, treating those who test positive as quickly as possible, and keeping them in care. Updated information on the CDC website provides more details for clinicians on how to have conversations about HIV with patients, the latest information about antiretroviral therapy, and details about prevention for partners including post- and pre-exposure prophylaxis (PEP and PreP), and condoms.
Eugene McCray, MD, director of the CDC’s Division of HIV/AIDS Prevention, emphasized that the CDC recommends HIV testing for all individuals aged 13-64 years at least once in their lives. He added that everyone who tests positive should seek medical care, that everyone with HIV deserves support to combat stigma, and that those at risk should be empowered to take advantage of proven effective prevention strategies.
Clinicians can access the updated CDC page on caring for HIV patients here.
SOURCE: Li Z et al. MMWR Morb Mortal Wkly Rep. 2019 March 18. doi: org/10.15585/mmwr.mm6811e1.
Approximately 80% of HIV infections in the United States in 2016 were spread by almost 40% of infected individuals who did not know their status or were not receiving care, according to data from the Centers for Disease Control and Prevention.
However, leadership at the Department of Health & Human Services has developed a “bold but completely achievable” plan to reduce HIV infections within the next decade, Vice Adm. Jerome M. Adams, MD, the U.S. surgeon general, said in a teleconference to announce the results of a new Vital Signs report on the impact of undiagnosed and untreated HIV.
In the early release Vital Signs from Morbidity and Mortality Weekly Report, Li Zihao, PhD, and his colleagues at the CDC used a model to estimate rates of HIV transmission in 2016 based on data from the National HIV Behavioral Surveillance on needle-sharing behavior and sexual behaviors. The overall transmission rate was 3.5/100,000 person-years. Of these transmissions, 73.0% were from men who have sex with men, 9.7% from intravenous drug users, and 12% from heterosexuals.
The percentages of transmissions for those who were acutely ill with HIV but unaware, not acutely ill but unaware, aware of HIV infection but not treated, receiving care but not virally suppressed, and receiving care and virally suppressed were 4.0%, 33.6%, 42.6%, 19.8%, and 0%, respectively, the researchers said.
The study “emphasizes the impact that HIV resources could have,” by showing the importance of identifying infected individuals early and using the tools now available to treat them before they can transmit the disease, Jonathan Mermin, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said during the conference.
“Today’s treatment regimens are simpler than those prescribed in the past, sometimes requiring only single-tablet formulations, with fewer side effects; most persons with HIV infection can achieve viral suppression within 6 months of initiating treatment,” the researchers wrote.
In the wake of the findings and at the start of the CDC’s 2019 National HIV Prevention Conference, the CDC proposed a federal initiative, “Ending the HIV Epidemic: A Plan for America.”
The goal is to reduce the incidence of new HIV infections by at least 90% over the next decade, starting with a focus on parts of the country with the highest disease burden, according to the CDC.
“Today’s Vital Signs report illustrates how a goal that once seemed impossible is now within our reach.” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during the conference. “If we increase access to testing and treatment for people with HIV, we could prevent a lion’s share of infections,” he said.
The plan involves working to identify individuals at risk, treating those who test positive as quickly as possible, and keeping them in care. Updated information on the CDC website provides more details for clinicians on how to have conversations about HIV with patients, the latest information about antiretroviral therapy, and details about prevention for partners including post- and pre-exposure prophylaxis (PEP and PreP), and condoms.
Eugene McCray, MD, director of the CDC’s Division of HIV/AIDS Prevention, emphasized that the CDC recommends HIV testing for all individuals aged 13-64 years at least once in their lives. He added that everyone who tests positive should seek medical care, that everyone with HIV deserves support to combat stigma, and that those at risk should be empowered to take advantage of proven effective prevention strategies.
Clinicians can access the updated CDC page on caring for HIV patients here.
SOURCE: Li Z et al. MMWR Morb Mortal Wkly Rep. 2019 March 18. doi: org/10.15585/mmwr.mm6811e1.
FROM THE CDC
FDA approves new valsartan generic
In response to a medication shortage, the Food and Drug Administration has approved a new generic of valsartan (Diovan), produced by Alkem Laboratories, for the treatment of high blood pressure and heart failure, the regulatory agency announced in a statement.
The FDA conducted an investigation into generic angiotensin II receptor blocker (ARB) products following reports of N-nitrosodimethylamine impurities being found in a separate valsartan product in the summer of 2018. Since that time, nitrosamine impurities have been detected in multiple ARBs, and as of March 1, 2019, hundreds of lots of ARBs produced by several companies have been recalled. The FDA has implemented new rules to prevent further contamination, but the ongoing recalls have caused a significant shortage.
“[To] address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products,” FDA commissioner Scott Gottlieb, MD, said in the statement.
For the new generic’s approval, the FDA assessed Alkem Laboratories’ manufacturing process and ensured that the company used proper testing methods to rule out the presence of nitrosamine impurities.
“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products,” Dr. Gottlieb said.
In response to a medication shortage, the Food and Drug Administration has approved a new generic of valsartan (Diovan), produced by Alkem Laboratories, for the treatment of high blood pressure and heart failure, the regulatory agency announced in a statement.
The FDA conducted an investigation into generic angiotensin II receptor blocker (ARB) products following reports of N-nitrosodimethylamine impurities being found in a separate valsartan product in the summer of 2018. Since that time, nitrosamine impurities have been detected in multiple ARBs, and as of March 1, 2019, hundreds of lots of ARBs produced by several companies have been recalled. The FDA has implemented new rules to prevent further contamination, but the ongoing recalls have caused a significant shortage.
“[To] address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products,” FDA commissioner Scott Gottlieb, MD, said in the statement.
For the new generic’s approval, the FDA assessed Alkem Laboratories’ manufacturing process and ensured that the company used proper testing methods to rule out the presence of nitrosamine impurities.
“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products,” Dr. Gottlieb said.
In response to a medication shortage, the Food and Drug Administration has approved a new generic of valsartan (Diovan), produced by Alkem Laboratories, for the treatment of high blood pressure and heart failure, the regulatory agency announced in a statement.
The FDA conducted an investigation into generic angiotensin II receptor blocker (ARB) products following reports of N-nitrosodimethylamine impurities being found in a separate valsartan product in the summer of 2018. Since that time, nitrosamine impurities have been detected in multiple ARBs, and as of March 1, 2019, hundreds of lots of ARBs produced by several companies have been recalled. The FDA has implemented new rules to prevent further contamination, but the ongoing recalls have caused a significant shortage.
“[To] address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products,” FDA commissioner Scott Gottlieb, MD, said in the statement.
For the new generic’s approval, the FDA assessed Alkem Laboratories’ manufacturing process and ensured that the company used proper testing methods to rule out the presence of nitrosamine impurities.
“We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products,” Dr. Gottlieb said.
FDA approves another trastuzumab biosimilar for HER2-positive breast cancer, gastric cancer
The Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar of Herceptin (trastuzumab), for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA approval was based on a review of a comprehensive data package, which included results from the REFLECTIONS B327-02 trial. In this trial, Trazimera was found to have clinical equivalence with trastuzumab in the first-line treatment setting in patients with HER2-positive metastatic breast cancer.
The most common adverse events associated with Trazimera in patients with breast cancer include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain. For patients with metastatic adenocarcinoma, the most common adverse events include low white and red blood cell counts; diarrhea; fatigue; swelling of the mouth lining, mucous membranes, nose, or throat; weight loss; upper respiratory tract infections; fever; low platelet counts; and change in taste.
“Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients. With the availability of biosimilars like Trazimera in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need,” Mark Pegram, MD, director of the breast oncology program at the Stanford Women’s Cancer Center at Stanford (Calif.) University, said in the press release.
Find the full press release on the Pfizer website.
The Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar of Herceptin (trastuzumab), for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA approval was based on a review of a comprehensive data package, which included results from the REFLECTIONS B327-02 trial. In this trial, Trazimera was found to have clinical equivalence with trastuzumab in the first-line treatment setting in patients with HER2-positive metastatic breast cancer.
The most common adverse events associated with Trazimera in patients with breast cancer include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain. For patients with metastatic adenocarcinoma, the most common adverse events include low white and red blood cell counts; diarrhea; fatigue; swelling of the mouth lining, mucous membranes, nose, or throat; weight loss; upper respiratory tract infections; fever; low platelet counts; and change in taste.
“Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients. With the availability of biosimilars like Trazimera in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need,” Mark Pegram, MD, director of the breast oncology program at the Stanford Women’s Cancer Center at Stanford (Calif.) University, said in the press release.
Find the full press release on the Pfizer website.
The Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar of Herceptin (trastuzumab), for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA approval was based on a review of a comprehensive data package, which included results from the REFLECTIONS B327-02 trial. In this trial, Trazimera was found to have clinical equivalence with trastuzumab in the first-line treatment setting in patients with HER2-positive metastatic breast cancer.
The most common adverse events associated with Trazimera in patients with breast cancer include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain. For patients with metastatic adenocarcinoma, the most common adverse events include low white and red blood cell counts; diarrhea; fatigue; swelling of the mouth lining, mucous membranes, nose, or throat; weight loss; upper respiratory tract infections; fever; low platelet counts; and change in taste.
“Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients. With the availability of biosimilars like Trazimera in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need,” Mark Pegram, MD, director of the breast oncology program at the Stanford Women’s Cancer Center at Stanford (Calif.) University, said in the press release.
Find the full press release on the Pfizer website.
FDA approves Tecentriq plus Abraxane in breast cancer
The Food and Drug Administration has granted accelerated approval for the combination of atezolizumab (Tecentriq) plus nanoparticle albumin–bound paclitaxel (nab-paclitaxel; Abraxane) for the treatment of adults with unresectable locally advanced or metastatic programmed death-ligand 1 (PD-L1)–positive triple-negative breast cancer (TNBC).
This conditional approval is granted to medicines that fill an unmet medical need for serious or life-threatening diseases or conditions, but the FDA may require confirmatory trials to provide verification and description of clinical benefit to allow continued approval.
The approval is based on the phase 3 IMpassion130 trial (NCT02425891), which enrolled 902 patients with unresectable, locally advanced or metastatic TNBC who had not received prior lines of chemo for metastatic disease, according to Genentech.
The multicenter, randomized, double-blind study has been evaluating the drug combination’s efficacy, safety, and pharmacokinetics. Compared with placebo plus nab-paclitaxel, atezolizumab/nab-paclitaxel demonstrated significantly superior progression-free survival (median PFS, 7.4 months vs. 4.8 months; hazard ratio, 0.60; 95% confidence interval, 0.48-0.77; P less than .0001).
The overall survival data for the intention-to-treat population remains immature, but further data will be shared with the FDA in the future, according to Genentech.
No new safety signals were seen in the atezolizumab/nab-paclitaxel arm, and the combination’s safety appeared consistent with the known safety profiles of each medicine individually.
The most common grade 3-4 events (occurring in more than 2% of patients) in the combination arm included low red blood cells, low white blood cells, feeling tired, low blood potassium level, and pneumonia.
The most common side effects (occurring in more than 20% of patients) in the combination arm included hair loss, tingling, nausea, diarrhea, headache, low red blood cells, low white blood cells, and decreased appetite.
Atezolizumab is a monoclonal antibody that binds to the PD-L1 receptor, which could possibly lead to the reactivation of T cells; however, atezolizumab also may interact with other cells in the body. Nab-paclitaxel is an injectable suspension of the common chemotherapy drug.
The Food and Drug Administration has granted accelerated approval for the combination of atezolizumab (Tecentriq) plus nanoparticle albumin–bound paclitaxel (nab-paclitaxel; Abraxane) for the treatment of adults with unresectable locally advanced or metastatic programmed death-ligand 1 (PD-L1)–positive triple-negative breast cancer (TNBC).
This conditional approval is granted to medicines that fill an unmet medical need for serious or life-threatening diseases or conditions, but the FDA may require confirmatory trials to provide verification and description of clinical benefit to allow continued approval.
The approval is based on the phase 3 IMpassion130 trial (NCT02425891), which enrolled 902 patients with unresectable, locally advanced or metastatic TNBC who had not received prior lines of chemo for metastatic disease, according to Genentech.
The multicenter, randomized, double-blind study has been evaluating the drug combination’s efficacy, safety, and pharmacokinetics. Compared with placebo plus nab-paclitaxel, atezolizumab/nab-paclitaxel demonstrated significantly superior progression-free survival (median PFS, 7.4 months vs. 4.8 months; hazard ratio, 0.60; 95% confidence interval, 0.48-0.77; P less than .0001).
The overall survival data for the intention-to-treat population remains immature, but further data will be shared with the FDA in the future, according to Genentech.
No new safety signals were seen in the atezolizumab/nab-paclitaxel arm, and the combination’s safety appeared consistent with the known safety profiles of each medicine individually.
The most common grade 3-4 events (occurring in more than 2% of patients) in the combination arm included low red blood cells, low white blood cells, feeling tired, low blood potassium level, and pneumonia.
The most common side effects (occurring in more than 20% of patients) in the combination arm included hair loss, tingling, nausea, diarrhea, headache, low red blood cells, low white blood cells, and decreased appetite.
Atezolizumab is a monoclonal antibody that binds to the PD-L1 receptor, which could possibly lead to the reactivation of T cells; however, atezolizumab also may interact with other cells in the body. Nab-paclitaxel is an injectable suspension of the common chemotherapy drug.
The Food and Drug Administration has granted accelerated approval for the combination of atezolizumab (Tecentriq) plus nanoparticle albumin–bound paclitaxel (nab-paclitaxel; Abraxane) for the treatment of adults with unresectable locally advanced or metastatic programmed death-ligand 1 (PD-L1)–positive triple-negative breast cancer (TNBC).
This conditional approval is granted to medicines that fill an unmet medical need for serious or life-threatening diseases or conditions, but the FDA may require confirmatory trials to provide verification and description of clinical benefit to allow continued approval.
The approval is based on the phase 3 IMpassion130 trial (NCT02425891), which enrolled 902 patients with unresectable, locally advanced or metastatic TNBC who had not received prior lines of chemo for metastatic disease, according to Genentech.
The multicenter, randomized, double-blind study has been evaluating the drug combination’s efficacy, safety, and pharmacokinetics. Compared with placebo plus nab-paclitaxel, atezolizumab/nab-paclitaxel demonstrated significantly superior progression-free survival (median PFS, 7.4 months vs. 4.8 months; hazard ratio, 0.60; 95% confidence interval, 0.48-0.77; P less than .0001).
The overall survival data for the intention-to-treat population remains immature, but further data will be shared with the FDA in the future, according to Genentech.
No new safety signals were seen in the atezolizumab/nab-paclitaxel arm, and the combination’s safety appeared consistent with the known safety profiles of each medicine individually.
The most common grade 3-4 events (occurring in more than 2% of patients) in the combination arm included low red blood cells, low white blood cells, feeling tired, low blood potassium level, and pneumonia.
The most common side effects (occurring in more than 20% of patients) in the combination arm included hair loss, tingling, nausea, diarrhea, headache, low red blood cells, low white blood cells, and decreased appetite.
Atezolizumab is a monoclonal antibody that binds to the PD-L1 receptor, which could possibly lead to the reactivation of T cells; however, atezolizumab also may interact with other cells in the body. Nab-paclitaxel is an injectable suspension of the common chemotherapy drug.
FDA approves patient-controlled injector for guselkumab
The Food and Drug Administration has in adults, the manufacturer announced.
FDA approval is based on results from the phase 3, multicenter, randomized ORION trial, according to a press release issued by Janssen. In a Self-Injection Assessment Questionnaire, patients who received the One-Press injection rated their satisfaction with self-injection a mean score of 9.18 (0 indicated least satisfaction, 10 indicated highest satisfaction) and rated ease of use at 9.24 (10 indicated “very easy”).
In addition, 81% of patients who received One-Press achieved a Investigator’s Global Assessment score of 0 or 1, and 76% achieved a Psoriasis Area Severity Index (PASI) 90 response after 16 weeks; no patients who received the placebo achieved either.
The most common adverse event during the ORION study was injection-site reaction; the most common adverse events associated with guselkumab, an interleukin-23 blocker, include upper respiratory infections, headache, injection-site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.
The Food and Drug Administration has in adults, the manufacturer announced.
FDA approval is based on results from the phase 3, multicenter, randomized ORION trial, according to a press release issued by Janssen. In a Self-Injection Assessment Questionnaire, patients who received the One-Press injection rated their satisfaction with self-injection a mean score of 9.18 (0 indicated least satisfaction, 10 indicated highest satisfaction) and rated ease of use at 9.24 (10 indicated “very easy”).
In addition, 81% of patients who received One-Press achieved a Investigator’s Global Assessment score of 0 or 1, and 76% achieved a Psoriasis Area Severity Index (PASI) 90 response after 16 weeks; no patients who received the placebo achieved either.
The most common adverse event during the ORION study was injection-site reaction; the most common adverse events associated with guselkumab, an interleukin-23 blocker, include upper respiratory infections, headache, injection-site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.
The Food and Drug Administration has in adults, the manufacturer announced.
FDA approval is based on results from the phase 3, multicenter, randomized ORION trial, according to a press release issued by Janssen. In a Self-Injection Assessment Questionnaire, patients who received the One-Press injection rated their satisfaction with self-injection a mean score of 9.18 (0 indicated least satisfaction, 10 indicated highest satisfaction) and rated ease of use at 9.24 (10 indicated “very easy”).
In addition, 81% of patients who received One-Press achieved a Investigator’s Global Assessment score of 0 or 1, and 76% achieved a Psoriasis Area Severity Index (PASI) 90 response after 16 weeks; no patients who received the placebo achieved either.
The most common adverse event during the ORION study was injection-site reaction; the most common adverse events associated with guselkumab, an interleukin-23 blocker, include upper respiratory infections, headache, injection-site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.
FDA urges caution with robotic devices in cancer surgery
A new safety communication from the Food and Drug Administration on the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries in women encourages physician-patient dialogue and suggests that, moving forward, data on specific oncologic outcomes – not only perioperative and short-term outcomes – are key.
The FDA is “warning patients and providers that the use of robotically assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in a statement.
The safety communication focuses on women and calls attention specifically to robotically-assisted mastectomy and hysterectomy for early cervical cancers. It says there is “limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”
The FDA cited a multicenter randomized trial that found that minimally invasive radical hysterectomy in women with cervical cancer (laparoscopic and robotically assisted) was associated with a lower rate of long-term survival compared with open surgery (N Engl J Med. 2018;379:1895-1904).
The communication does not refer to any other specific studies. Regarding current evidence on robotically-assisted mastectomies, the FDA safety communication says simply that safety and effectiveness have not been established and that the agency is “aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.”
Robotically-assisted mastectomy
Walton Taylor, MD, president of the American Society of Breast Surgeons and a surgeon with Texas Health Physicians Group in Dallas, said that the FDA’s concern is valid. “I really hope that robotic surgery turns out to be good [for mastectomy]. It’s awesome technology that can be great for patients,” he said. “But we have to gather real data that shows that long-term and short-term outcomes – from a cancer standpoint – are as good as with the open procedure ... that there aren’t negative unintended consequences.”
Right now, Dr. Taylor said, robotic mastectomy “is not commonplace by any means.”
The technique for robotic nipple-sparing mastectomy (NSM) was first described by Antonio Toesca, MD, of the European Institute of Oncology in Milan (Ann Surg. 2017;266[2]:e28-e30).
In an editorial published recently in Annals of Surgical Oncology, Jesse C. Selber, MD, MPH, of the department of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston, described the technique as a “natural next step in the evolution of minimally invasive breast surgery that has the potential to mitigate the challenges associated with traditional NSM” (Ann Surg Oncol. 2019;26[1]:10-11). Robotic nipple-sparing mastectomy is catching on in Europe” with very promising early results, he wrote.
At least a couple of practices promoted their performance of robotic mastectomy last year. Northwell Health, a large network of hospitals, outpatient facilities, and physicians in New York, announced in March 2018 that Neil Tanna, MD, and Alan Kadison, MD, of the divisions of plastic and reconstructive surgery and surgical oncology, respectively, had performed the first robotic nipple-sparing mastectomy and breast reconstructive surgery in the United States. Their patient carried the BRCA gene and had a preventive mastectomy at Northwell Health’s Long Island Jewish Medical Center.
In October 2018, a surgeon in Tinton Falls, N.J., Stephen Chagares, MD, announced that he had performed the first robotic nipple-sparing mastectomy with reconstruction in a patient with breast cancer at Monmouth Medical Center. His press release described a 3-cm incision “to the side of the breast, tucked neatly behind the armpit.” Both Dr. Chagares and Dr. Tanna had traveled to Milan to train with Dr. Toesca, according to the press releases.
Both of these cases – as well as a decision by Monmouth Medical Center in December 2018 to suspend the surgery pending further review – were mentioned in a letter submitted to the FDA in mid-December by Hooman Noorchashm, MD, PhD, a Philadelphia cardiothoracic surgeon-turned-patient-advocate whose wife Amy Josephine Reed, MD, PhD, died of uterine cancer in May 2017 following a laparoscopic hysterectomy performed with a power morcellator.
In his complaint, Dr. Noorchashm urged the agency to issue a warning about the “potentially dangerous/premature application” of robotic mastectomy for the treatment of breast cancer or BRCA carrier status outside the setting of randomized controlled trials with primary cancer–related outcomes metrics or an investigational device exemption from the FDA. (Receipt of the letter was acknowledged by the Allegation of Regulatory Misconduct Branch of the FDA several days later.)
In an interview, Dr. Noorchashm said he wants to see a regulatory framework that doesn’t allow 510(k) devices (devices requiring a premarket notification to the FDA) to modify an existing standard of care without having been shown to have noninferior primary outcomes. When devices are used in the diagnosis or treatment of cancerous or potentially cancerous tissue, he said, this means primary oncologic outcomes must be shown to be noninferior.
“When you have 510(k) devices able to inject themselves and affect existing standards of care without any sort of clinical trial requirement, you get the standard of care changing without any outcomes data to back it up,” he said. “That’s what happened with the power morcellator. Physicians started using it without any sort of prospective data, level 1 outcomes data, and it dramatically changed the conduct of hysterectomies.”
In its safety communication, the FDA encourages the establishment of patient registries to gather data on robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. It also says that while the agency’s evaluation of the devices has generally focused on complication rates at 30 days, the FDA “anticipates” that their use in the prevention or treatment of cancer “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”
The American Society of Breast Surgeons has a Nipple Sparing Mastectomy Registry that is collecting oncologic outcomes as well as aesthetic outcomes and other metrics on 2,000 patients. “In the last year or two, we’ve seen nipple-sparing mastectomy become much more commonplace,” said Dr. Taylor. Thus far, the registry does not include robotic procedures, but “if there were interest in a registry specifically for robotic nipple-sparing mastectomy, we would do it in a heartbeat.”
Gynecologic oncology surgery
The randomized controlled study on radical hysterectomy for cervical cancer that caught the FDA’s attention reported lower rates of disease-free survival at 4.5 years with minimally invasive surgery than with open abdominal surgery (86% versus 96.5%) and lower rates of overall survival at 3 years.
The phase 3 multicenter Laparoscopic Approach to Cervical Cancer trial recruited more than 600 women with stage IA1, IA2, or IB1 cervical cancer. Most (91.9%) had IB1 disease and either squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Differences in the outcomes remained after adjustment for age, body mass index, disease stage, lymphovascular invasion, and lymph-node involvement. The findings led to early termination of the study.
The study did not single out robotically-assisted surgery. It was a two-arm study and was “not powered to analyze laparoscopy versus robotics,” lead author Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center, said in an interview. “But based on our numbers, we saw no difference [in outcomes] between the two groups.” Of the patients who underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% underwent robot-assisted surgery.
The study, funded by MD Anderson and Medtronic, has been criticized for potential design and conduct issues. Outside experts pointed out that the study involved extremely small numbers of patients at each of the 33 participating centers, and that cancer recurrences were clustered at 14 of these centers. It’s important to appreciate, Dr. Ramirez said in the interview, that the majority of patients were accrued in these 14 centers.
In its safety communication, the FDA noted that other researchers have reported no statistically significant difference in long-term survival when open and minimally invasive approaches to radical hysterectomy for cervical cancer have been compared.
Asked to comment on the FDA’s safety communication, Dwight D. Im, MD, who leads the National Institute of Robotic Surgery at Mercy in Baltimore, said in an e-mail that “while robotic surgery may advance into new areas, such as mastectomy and cancer prevention, more research must be done and this should be part of any conversation between gyn-surgeons who are experienced in the realm of robotic surgery, and their patients.”
Regarding the treatment of cervical cancer, “I think it is safe to say that most gynecologic oncologists now offer only open laparotomies until we have more data comparing open to minimally invasive (laparoscopic and robotic) approaches,” he said.
The FDA said in a briefing document accompanying the safety communication that it has received a “small number of medical device reports of patient injury when [robotically-assisted surgical devices] are used in cancer-related procedures.”
According to the FDA spokesperson, 5 of 32 medical device reports received between January 2016 and December 2018 describe patients who underwent hysterectomy and experienced metastases afterward. It does not appear that any of the 5 cases were a direct result of a system error or device malfunction, and the complications described in the reports are not unique to robotically-assisted surgical devices, the spokesperson said.
The safety communication “reflects the agency’s commitment to enhancing the oversight of device safety as part of our Medical Device Action Plan, as well as the agency’s ongoing commitment to advancing women’s health.”
Dr. Taylor reported that he has no current financial disclosures. Dr. Ramirez reported to the New England Journal of Medicine that he had no relevant disclosures. Dr. Im reported that he is a speaker for Intuitive Surgical, which manufacturers the da Vinci Surgical System, as well as for Conmed and Ethicon.
A new safety communication from the Food and Drug Administration on the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries in women encourages physician-patient dialogue and suggests that, moving forward, data on specific oncologic outcomes – not only perioperative and short-term outcomes – are key.
The FDA is “warning patients and providers that the use of robotically assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in a statement.
The safety communication focuses on women and calls attention specifically to robotically-assisted mastectomy and hysterectomy for early cervical cancers. It says there is “limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”
The FDA cited a multicenter randomized trial that found that minimally invasive radical hysterectomy in women with cervical cancer (laparoscopic and robotically assisted) was associated with a lower rate of long-term survival compared with open surgery (N Engl J Med. 2018;379:1895-1904).
The communication does not refer to any other specific studies. Regarding current evidence on robotically-assisted mastectomies, the FDA safety communication says simply that safety and effectiveness have not been established and that the agency is “aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.”
Robotically-assisted mastectomy
Walton Taylor, MD, president of the American Society of Breast Surgeons and a surgeon with Texas Health Physicians Group in Dallas, said that the FDA’s concern is valid. “I really hope that robotic surgery turns out to be good [for mastectomy]. It’s awesome technology that can be great for patients,” he said. “But we have to gather real data that shows that long-term and short-term outcomes – from a cancer standpoint – are as good as with the open procedure ... that there aren’t negative unintended consequences.”
Right now, Dr. Taylor said, robotic mastectomy “is not commonplace by any means.”
The technique for robotic nipple-sparing mastectomy (NSM) was first described by Antonio Toesca, MD, of the European Institute of Oncology in Milan (Ann Surg. 2017;266[2]:e28-e30).
In an editorial published recently in Annals of Surgical Oncology, Jesse C. Selber, MD, MPH, of the department of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston, described the technique as a “natural next step in the evolution of minimally invasive breast surgery that has the potential to mitigate the challenges associated with traditional NSM” (Ann Surg Oncol. 2019;26[1]:10-11). Robotic nipple-sparing mastectomy is catching on in Europe” with very promising early results, he wrote.
At least a couple of practices promoted their performance of robotic mastectomy last year. Northwell Health, a large network of hospitals, outpatient facilities, and physicians in New York, announced in March 2018 that Neil Tanna, MD, and Alan Kadison, MD, of the divisions of plastic and reconstructive surgery and surgical oncology, respectively, had performed the first robotic nipple-sparing mastectomy and breast reconstructive surgery in the United States. Their patient carried the BRCA gene and had a preventive mastectomy at Northwell Health’s Long Island Jewish Medical Center.
In October 2018, a surgeon in Tinton Falls, N.J., Stephen Chagares, MD, announced that he had performed the first robotic nipple-sparing mastectomy with reconstruction in a patient with breast cancer at Monmouth Medical Center. His press release described a 3-cm incision “to the side of the breast, tucked neatly behind the armpit.” Both Dr. Chagares and Dr. Tanna had traveled to Milan to train with Dr. Toesca, according to the press releases.
Both of these cases – as well as a decision by Monmouth Medical Center in December 2018 to suspend the surgery pending further review – were mentioned in a letter submitted to the FDA in mid-December by Hooman Noorchashm, MD, PhD, a Philadelphia cardiothoracic surgeon-turned-patient-advocate whose wife Amy Josephine Reed, MD, PhD, died of uterine cancer in May 2017 following a laparoscopic hysterectomy performed with a power morcellator.
In his complaint, Dr. Noorchashm urged the agency to issue a warning about the “potentially dangerous/premature application” of robotic mastectomy for the treatment of breast cancer or BRCA carrier status outside the setting of randomized controlled trials with primary cancer–related outcomes metrics or an investigational device exemption from the FDA. (Receipt of the letter was acknowledged by the Allegation of Regulatory Misconduct Branch of the FDA several days later.)
In an interview, Dr. Noorchashm said he wants to see a regulatory framework that doesn’t allow 510(k) devices (devices requiring a premarket notification to the FDA) to modify an existing standard of care without having been shown to have noninferior primary outcomes. When devices are used in the diagnosis or treatment of cancerous or potentially cancerous tissue, he said, this means primary oncologic outcomes must be shown to be noninferior.
“When you have 510(k) devices able to inject themselves and affect existing standards of care without any sort of clinical trial requirement, you get the standard of care changing without any outcomes data to back it up,” he said. “That’s what happened with the power morcellator. Physicians started using it without any sort of prospective data, level 1 outcomes data, and it dramatically changed the conduct of hysterectomies.”
In its safety communication, the FDA encourages the establishment of patient registries to gather data on robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. It also says that while the agency’s evaluation of the devices has generally focused on complication rates at 30 days, the FDA “anticipates” that their use in the prevention or treatment of cancer “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”
The American Society of Breast Surgeons has a Nipple Sparing Mastectomy Registry that is collecting oncologic outcomes as well as aesthetic outcomes and other metrics on 2,000 patients. “In the last year or two, we’ve seen nipple-sparing mastectomy become much more commonplace,” said Dr. Taylor. Thus far, the registry does not include robotic procedures, but “if there were interest in a registry specifically for robotic nipple-sparing mastectomy, we would do it in a heartbeat.”
Gynecologic oncology surgery
The randomized controlled study on radical hysterectomy for cervical cancer that caught the FDA’s attention reported lower rates of disease-free survival at 4.5 years with minimally invasive surgery than with open abdominal surgery (86% versus 96.5%) and lower rates of overall survival at 3 years.
The phase 3 multicenter Laparoscopic Approach to Cervical Cancer trial recruited more than 600 women with stage IA1, IA2, or IB1 cervical cancer. Most (91.9%) had IB1 disease and either squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Differences in the outcomes remained after adjustment for age, body mass index, disease stage, lymphovascular invasion, and lymph-node involvement. The findings led to early termination of the study.
The study did not single out robotically-assisted surgery. It was a two-arm study and was “not powered to analyze laparoscopy versus robotics,” lead author Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center, said in an interview. “But based on our numbers, we saw no difference [in outcomes] between the two groups.” Of the patients who underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% underwent robot-assisted surgery.
The study, funded by MD Anderson and Medtronic, has been criticized for potential design and conduct issues. Outside experts pointed out that the study involved extremely small numbers of patients at each of the 33 participating centers, and that cancer recurrences were clustered at 14 of these centers. It’s important to appreciate, Dr. Ramirez said in the interview, that the majority of patients were accrued in these 14 centers.
In its safety communication, the FDA noted that other researchers have reported no statistically significant difference in long-term survival when open and minimally invasive approaches to radical hysterectomy for cervical cancer have been compared.
Asked to comment on the FDA’s safety communication, Dwight D. Im, MD, who leads the National Institute of Robotic Surgery at Mercy in Baltimore, said in an e-mail that “while robotic surgery may advance into new areas, such as mastectomy and cancer prevention, more research must be done and this should be part of any conversation between gyn-surgeons who are experienced in the realm of robotic surgery, and their patients.”
Regarding the treatment of cervical cancer, “I think it is safe to say that most gynecologic oncologists now offer only open laparotomies until we have more data comparing open to minimally invasive (laparoscopic and robotic) approaches,” he said.
The FDA said in a briefing document accompanying the safety communication that it has received a “small number of medical device reports of patient injury when [robotically-assisted surgical devices] are used in cancer-related procedures.”
According to the FDA spokesperson, 5 of 32 medical device reports received between January 2016 and December 2018 describe patients who underwent hysterectomy and experienced metastases afterward. It does not appear that any of the 5 cases were a direct result of a system error or device malfunction, and the complications described in the reports are not unique to robotically-assisted surgical devices, the spokesperson said.
The safety communication “reflects the agency’s commitment to enhancing the oversight of device safety as part of our Medical Device Action Plan, as well as the agency’s ongoing commitment to advancing women’s health.”
Dr. Taylor reported that he has no current financial disclosures. Dr. Ramirez reported to the New England Journal of Medicine that he had no relevant disclosures. Dr. Im reported that he is a speaker for Intuitive Surgical, which manufacturers the da Vinci Surgical System, as well as for Conmed and Ethicon.
A new safety communication from the Food and Drug Administration on the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries in women encourages physician-patient dialogue and suggests that, moving forward, data on specific oncologic outcomes – not only perioperative and short-term outcomes – are key.
The FDA is “warning patients and providers that the use of robotically assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in a statement.
The safety communication focuses on women and calls attention specifically to robotically-assisted mastectomy and hysterectomy for early cervical cancers. It says there is “limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”
The FDA cited a multicenter randomized trial that found that minimally invasive radical hysterectomy in women with cervical cancer (laparoscopic and robotically assisted) was associated with a lower rate of long-term survival compared with open surgery (N Engl J Med. 2018;379:1895-1904).
The communication does not refer to any other specific studies. Regarding current evidence on robotically-assisted mastectomies, the FDA safety communication says simply that safety and effectiveness have not been established and that the agency is “aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.”
Robotically-assisted mastectomy
Walton Taylor, MD, president of the American Society of Breast Surgeons and a surgeon with Texas Health Physicians Group in Dallas, said that the FDA’s concern is valid. “I really hope that robotic surgery turns out to be good [for mastectomy]. It’s awesome technology that can be great for patients,” he said. “But we have to gather real data that shows that long-term and short-term outcomes – from a cancer standpoint – are as good as with the open procedure ... that there aren’t negative unintended consequences.”
Right now, Dr. Taylor said, robotic mastectomy “is not commonplace by any means.”
The technique for robotic nipple-sparing mastectomy (NSM) was first described by Antonio Toesca, MD, of the European Institute of Oncology in Milan (Ann Surg. 2017;266[2]:e28-e30).
In an editorial published recently in Annals of Surgical Oncology, Jesse C. Selber, MD, MPH, of the department of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston, described the technique as a “natural next step in the evolution of minimally invasive breast surgery that has the potential to mitigate the challenges associated with traditional NSM” (Ann Surg Oncol. 2019;26[1]:10-11). Robotic nipple-sparing mastectomy is catching on in Europe” with very promising early results, he wrote.
At least a couple of practices promoted their performance of robotic mastectomy last year. Northwell Health, a large network of hospitals, outpatient facilities, and physicians in New York, announced in March 2018 that Neil Tanna, MD, and Alan Kadison, MD, of the divisions of plastic and reconstructive surgery and surgical oncology, respectively, had performed the first robotic nipple-sparing mastectomy and breast reconstructive surgery in the United States. Their patient carried the BRCA gene and had a preventive mastectomy at Northwell Health’s Long Island Jewish Medical Center.
In October 2018, a surgeon in Tinton Falls, N.J., Stephen Chagares, MD, announced that he had performed the first robotic nipple-sparing mastectomy with reconstruction in a patient with breast cancer at Monmouth Medical Center. His press release described a 3-cm incision “to the side of the breast, tucked neatly behind the armpit.” Both Dr. Chagares and Dr. Tanna had traveled to Milan to train with Dr. Toesca, according to the press releases.
Both of these cases – as well as a decision by Monmouth Medical Center in December 2018 to suspend the surgery pending further review – were mentioned in a letter submitted to the FDA in mid-December by Hooman Noorchashm, MD, PhD, a Philadelphia cardiothoracic surgeon-turned-patient-advocate whose wife Amy Josephine Reed, MD, PhD, died of uterine cancer in May 2017 following a laparoscopic hysterectomy performed with a power morcellator.
In his complaint, Dr. Noorchashm urged the agency to issue a warning about the “potentially dangerous/premature application” of robotic mastectomy for the treatment of breast cancer or BRCA carrier status outside the setting of randomized controlled trials with primary cancer–related outcomes metrics or an investigational device exemption from the FDA. (Receipt of the letter was acknowledged by the Allegation of Regulatory Misconduct Branch of the FDA several days later.)
In an interview, Dr. Noorchashm said he wants to see a regulatory framework that doesn’t allow 510(k) devices (devices requiring a premarket notification to the FDA) to modify an existing standard of care without having been shown to have noninferior primary outcomes. When devices are used in the diagnosis or treatment of cancerous or potentially cancerous tissue, he said, this means primary oncologic outcomes must be shown to be noninferior.
“When you have 510(k) devices able to inject themselves and affect existing standards of care without any sort of clinical trial requirement, you get the standard of care changing without any outcomes data to back it up,” he said. “That’s what happened with the power morcellator. Physicians started using it without any sort of prospective data, level 1 outcomes data, and it dramatically changed the conduct of hysterectomies.”
In its safety communication, the FDA encourages the establishment of patient registries to gather data on robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. It also says that while the agency’s evaluation of the devices has generally focused on complication rates at 30 days, the FDA “anticipates” that their use in the prevention or treatment of cancer “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”
The American Society of Breast Surgeons has a Nipple Sparing Mastectomy Registry that is collecting oncologic outcomes as well as aesthetic outcomes and other metrics on 2,000 patients. “In the last year or two, we’ve seen nipple-sparing mastectomy become much more commonplace,” said Dr. Taylor. Thus far, the registry does not include robotic procedures, but “if there were interest in a registry specifically for robotic nipple-sparing mastectomy, we would do it in a heartbeat.”
Gynecologic oncology surgery
The randomized controlled study on radical hysterectomy for cervical cancer that caught the FDA’s attention reported lower rates of disease-free survival at 4.5 years with minimally invasive surgery than with open abdominal surgery (86% versus 96.5%) and lower rates of overall survival at 3 years.
The phase 3 multicenter Laparoscopic Approach to Cervical Cancer trial recruited more than 600 women with stage IA1, IA2, or IB1 cervical cancer. Most (91.9%) had IB1 disease and either squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Differences in the outcomes remained after adjustment for age, body mass index, disease stage, lymphovascular invasion, and lymph-node involvement. The findings led to early termination of the study.
The study did not single out robotically-assisted surgery. It was a two-arm study and was “not powered to analyze laparoscopy versus robotics,” lead author Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center, said in an interview. “But based on our numbers, we saw no difference [in outcomes] between the two groups.” Of the patients who underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% underwent robot-assisted surgery.
The study, funded by MD Anderson and Medtronic, has been criticized for potential design and conduct issues. Outside experts pointed out that the study involved extremely small numbers of patients at each of the 33 participating centers, and that cancer recurrences were clustered at 14 of these centers. It’s important to appreciate, Dr. Ramirez said in the interview, that the majority of patients were accrued in these 14 centers.
In its safety communication, the FDA noted that other researchers have reported no statistically significant difference in long-term survival when open and minimally invasive approaches to radical hysterectomy for cervical cancer have been compared.
Asked to comment on the FDA’s safety communication, Dwight D. Im, MD, who leads the National Institute of Robotic Surgery at Mercy in Baltimore, said in an e-mail that “while robotic surgery may advance into new areas, such as mastectomy and cancer prevention, more research must be done and this should be part of any conversation between gyn-surgeons who are experienced in the realm of robotic surgery, and their patients.”
Regarding the treatment of cervical cancer, “I think it is safe to say that most gynecologic oncologists now offer only open laparotomies until we have more data comparing open to minimally invasive (laparoscopic and robotic) approaches,” he said.
The FDA said in a briefing document accompanying the safety communication that it has received a “small number of medical device reports of patient injury when [robotically-assisted surgical devices] are used in cancer-related procedures.”
According to the FDA spokesperson, 5 of 32 medical device reports received between January 2016 and December 2018 describe patients who underwent hysterectomy and experienced metastases afterward. It does not appear that any of the 5 cases were a direct result of a system error or device malfunction, and the complications described in the reports are not unique to robotically-assisted surgical devices, the spokesperson said.
The safety communication “reflects the agency’s commitment to enhancing the oversight of device safety as part of our Medical Device Action Plan, as well as the agency’s ongoing commitment to advancing women’s health.”
Dr. Taylor reported that he has no current financial disclosures. Dr. Ramirez reported to the New England Journal of Medicine that he had no relevant disclosures. Dr. Im reported that he is a speaker for Intuitive Surgical, which manufacturers the da Vinci Surgical System, as well as for Conmed and Ethicon.
FDA approves intranasal esketamine for refractory major depressive disorder
The spray (Spravato; Janssen Pharmaceuticals) will come in tamper-resistant prepackaged units of one, two, or three devices to deliver the prescribed doses of 28 mg, 56 mg, or 84 mg, respectively. To reduce the risk of diversion, misuse, or abuse, the drug will managed under an FDA Risk Evaluation and Management Strategy (REMS). It will only be available to prescribing clinicians who have undergone training on the risks of esketamine and the importance of monitoring patients after their dose is administered. Facilities licensed to dispense esketamine must have the ability to medically monitor patients for at least 2 hours after administration. Patients will self-administer the spray and will not be able to take any of it home.
The REMS will require both prescriber and the patient to both sign a Patient Enrollment Form clearly stating that patients understand the necessity of assisted transport to leave the health care facility and that there should be no driving or use of heavy machinery for the rest of the day on which they are treated.
A boxed warning on the label will note that patients are at risk for sedation and difficulty with attention, judgment, and thinking (dissociation); abuse and misuse; and suicidal thoughts and behaviors after administration of the drug.
Despite the FDA’s caveats, the approval of intranasal esketamine is seen as a substantial win for the psychiatric community, Tiffany Farchione, MD, acting director of the FDA division of psychiatry products, said in a statement. “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition.”
“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, MD, PhD, global head of Janssen Research and Development.
The company “is working quickly to educate and certify treatment centers in accordance with the REMS so that health care providers can offer Spravato to appropriate patients,” according to a statement from Janssen. “Later this month, patients can visit www.SPRAVATO.com for a locater tool and to sign up to receive alerts when new treatment centers are available.”
Intranasal esketamine was evaluated in three short-term clinical trials and one longer-term maintenance-of-effect trial. One of the studies demonstrated a clinically significant effect in depression severity, in as little as 2 days for some patients. The two other short-term trials did not show significant benefit. However, in the maintenance study, patients in stable remission or with stable response who continued treatment with esketamine plus an oral antidepressant experienced a significantly longer time to relapse of depressive symptoms than patients on placebo spray plus an oral antidepressant. The most common side effects were disassociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, increased blood pressure, vomiting, and feeling drunk.
Patients with unstable or poorly controlled hypertension or pre-existing aneurysmal vascular disorders might be at increased risk for adverse cardiovascular or cerebrovascular effects. Esketamine might impair attention, judgment, thinking, reaction speed, and motor skills. It may cause fetal harm; women of childbearing age should be on reliable contraception. Breastfeeding women should not use it.
.
I’m not surprised by the FDA decision, given the strong endorsement from the advisory committees in mid-February based on the drug’s benefit-to-risk evaluation. This is an important advance for our field, and the FDA approval will allow more patients who suffer from treatment-resistant depression to gain access to this medication.
To date, ketamine (not the intranasal esketamine spray) has been offered primarily on a fee-for-service basis or in the context of a clinical trial. I anticipate this treatment to receive broad insurance coverage, but this remains to be determined.
Dr. Sanjay J. Mathew is the Marjorie Bintliff Johnson and Raleigh White Johnson Jr. Vice Chair for Research and professor in the Menninger department of psychiatry & behavioral sciences at the Baylor College of Medicine. He also is affiliated with the Michael E. Debakey VA Medical Center in Houston. Dr. Mathew has served as a consultant for and has had research funded by Janssen Pharmaceuticals.
I’m not surprised by the FDA decision, given the strong endorsement from the advisory committees in mid-February based on the drug’s benefit-to-risk evaluation. This is an important advance for our field, and the FDA approval will allow more patients who suffer from treatment-resistant depression to gain access to this medication.
To date, ketamine (not the intranasal esketamine spray) has been offered primarily on a fee-for-service basis or in the context of a clinical trial. I anticipate this treatment to receive broad insurance coverage, but this remains to be determined.
Dr. Sanjay J. Mathew is the Marjorie Bintliff Johnson and Raleigh White Johnson Jr. Vice Chair for Research and professor in the Menninger department of psychiatry & behavioral sciences at the Baylor College of Medicine. He also is affiliated with the Michael E. Debakey VA Medical Center in Houston. Dr. Mathew has served as a consultant for and has had research funded by Janssen Pharmaceuticals.
I’m not surprised by the FDA decision, given the strong endorsement from the advisory committees in mid-February based on the drug’s benefit-to-risk evaluation. This is an important advance for our field, and the FDA approval will allow more patients who suffer from treatment-resistant depression to gain access to this medication.
To date, ketamine (not the intranasal esketamine spray) has been offered primarily on a fee-for-service basis or in the context of a clinical trial. I anticipate this treatment to receive broad insurance coverage, but this remains to be determined.
Dr. Sanjay J. Mathew is the Marjorie Bintliff Johnson and Raleigh White Johnson Jr. Vice Chair for Research and professor in the Menninger department of psychiatry & behavioral sciences at the Baylor College of Medicine. He also is affiliated with the Michael E. Debakey VA Medical Center in Houston. Dr. Mathew has served as a consultant for and has had research funded by Janssen Pharmaceuticals.
The spray (Spravato; Janssen Pharmaceuticals) will come in tamper-resistant prepackaged units of one, two, or three devices to deliver the prescribed doses of 28 mg, 56 mg, or 84 mg, respectively. To reduce the risk of diversion, misuse, or abuse, the drug will managed under an FDA Risk Evaluation and Management Strategy (REMS). It will only be available to prescribing clinicians who have undergone training on the risks of esketamine and the importance of monitoring patients after their dose is administered. Facilities licensed to dispense esketamine must have the ability to medically monitor patients for at least 2 hours after administration. Patients will self-administer the spray and will not be able to take any of it home.
The REMS will require both prescriber and the patient to both sign a Patient Enrollment Form clearly stating that patients understand the necessity of assisted transport to leave the health care facility and that there should be no driving or use of heavy machinery for the rest of the day on which they are treated.
A boxed warning on the label will note that patients are at risk for sedation and difficulty with attention, judgment, and thinking (dissociation); abuse and misuse; and suicidal thoughts and behaviors after administration of the drug.
Despite the FDA’s caveats, the approval of intranasal esketamine is seen as a substantial win for the psychiatric community, Tiffany Farchione, MD, acting director of the FDA division of psychiatry products, said in a statement. “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition.”
“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, MD, PhD, global head of Janssen Research and Development.
The company “is working quickly to educate and certify treatment centers in accordance with the REMS so that health care providers can offer Spravato to appropriate patients,” according to a statement from Janssen. “Later this month, patients can visit www.SPRAVATO.com for a locater tool and to sign up to receive alerts when new treatment centers are available.”
Intranasal esketamine was evaluated in three short-term clinical trials and one longer-term maintenance-of-effect trial. One of the studies demonstrated a clinically significant effect in depression severity, in as little as 2 days for some patients. The two other short-term trials did not show significant benefit. However, in the maintenance study, patients in stable remission or with stable response who continued treatment with esketamine plus an oral antidepressant experienced a significantly longer time to relapse of depressive symptoms than patients on placebo spray plus an oral antidepressant. The most common side effects were disassociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, increased blood pressure, vomiting, and feeling drunk.
Patients with unstable or poorly controlled hypertension or pre-existing aneurysmal vascular disorders might be at increased risk for adverse cardiovascular or cerebrovascular effects. Esketamine might impair attention, judgment, thinking, reaction speed, and motor skills. It may cause fetal harm; women of childbearing age should be on reliable contraception. Breastfeeding women should not use it.
.
The spray (Spravato; Janssen Pharmaceuticals) will come in tamper-resistant prepackaged units of one, two, or three devices to deliver the prescribed doses of 28 mg, 56 mg, or 84 mg, respectively. To reduce the risk of diversion, misuse, or abuse, the drug will managed under an FDA Risk Evaluation and Management Strategy (REMS). It will only be available to prescribing clinicians who have undergone training on the risks of esketamine and the importance of monitoring patients after their dose is administered. Facilities licensed to dispense esketamine must have the ability to medically monitor patients for at least 2 hours after administration. Patients will self-administer the spray and will not be able to take any of it home.
The REMS will require both prescriber and the patient to both sign a Patient Enrollment Form clearly stating that patients understand the necessity of assisted transport to leave the health care facility and that there should be no driving or use of heavy machinery for the rest of the day on which they are treated.
A boxed warning on the label will note that patients are at risk for sedation and difficulty with attention, judgment, and thinking (dissociation); abuse and misuse; and suicidal thoughts and behaviors after administration of the drug.
Despite the FDA’s caveats, the approval of intranasal esketamine is seen as a substantial win for the psychiatric community, Tiffany Farchione, MD, acting director of the FDA division of psychiatry products, said in a statement. “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition.”
“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, MD, PhD, global head of Janssen Research and Development.
The company “is working quickly to educate and certify treatment centers in accordance with the REMS so that health care providers can offer Spravato to appropriate patients,” according to a statement from Janssen. “Later this month, patients can visit www.SPRAVATO.com for a locater tool and to sign up to receive alerts when new treatment centers are available.”
Intranasal esketamine was evaluated in three short-term clinical trials and one longer-term maintenance-of-effect trial. One of the studies demonstrated a clinically significant effect in depression severity, in as little as 2 days for some patients. The two other short-term trials did not show significant benefit. However, in the maintenance study, patients in stable remission or with stable response who continued treatment with esketamine plus an oral antidepressant experienced a significantly longer time to relapse of depressive symptoms than patients on placebo spray plus an oral antidepressant. The most common side effects were disassociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, increased blood pressure, vomiting, and feeling drunk.
Patients with unstable or poorly controlled hypertension or pre-existing aneurysmal vascular disorders might be at increased risk for adverse cardiovascular or cerebrovascular effects. Esketamine might impair attention, judgment, thinking, reaction speed, and motor skills. It may cause fetal harm; women of childbearing age should be on reliable contraception. Breastfeeding women should not use it.
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Scott Gottlieb to step down as FDA commissioner
According to reports, he is stepping down to spend more time with his family, who live in Westport, Conn. He splits time between there and Washington. He was confirmed by the Senate in May 2017 with five Democrats and one independent joining Republicans in voting him in.
President Trump confirmed Dr. Gottlieb’s resignation, praising him in a tweet for the “terrific job” he has done in this role and commending his efforts to help “us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. ”
Dr. Gottlieb’s legacy may be his work on regulating e-cigarettes, although that work is unfinished. His passion for this subject can be found in a statement made in Nov. 2018, announcing an advanced notice of proposed rule making to regulate e-cigarettes.
“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” Dr. Gottlieb said in the statement.
More recently, the agency announced March 4 enforcement actions aimed at both retailers and manufacturers, including requesting a meeting with Walgreens to discuss the nearly 1,800 violations the chain has amassed across the country for selling tobacco products to minors.
“Because tobacco use is almost always initiated and established during adolescence, early intervention ‒ including making sure tobacco products aren’t being marketed to, sold to, or used by kids ‒ is critical,” he said in announcing the enforcement actions. He added that the FDA will “continue vigorous enforcement activities, with a sustained campaign to monitor, penalize, and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ Internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products. The FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.”
The American Heart Association praised Dr. Gottlieb’s work.
“Commissioner Gottlieb departs the FDA having established himself as a tireless champion of tobacco control,” the organization said in a statement. “He elevated the war on tobacco use – and particularly the epidemic of electronic cigarette use among youth – to unprecedented levels. Because of his efforts, millions more people nationwide are aware of the grave threats posed by e-cigarettes and other tobacco products that are addicting a new generation of youth. We urge the FDA in the strongest possible terms to move forward with effective regulation of an industry that continues to prioritize profits over the lives of consumers.”
Department of Health & Human Services Secretary Alex Azar acknowledged Dr. Gottlieb’s work in combating youth e-cigarette use among a number of areas that the outgoing official has had a positive impact on.
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Secretary Azar said in a statement. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
Under his leadership, FDA has approved a record number of generic drugs, although many still are not on the market yet.
In the area of opioids, his tenure could be a mixed bag as the FDA on the one hand removed an opioid product from the market, but on the other, controversially approved a new, powerful one.
According to reports, he is stepping down to spend more time with his family, who live in Westport, Conn. He splits time between there and Washington. He was confirmed by the Senate in May 2017 with five Democrats and one independent joining Republicans in voting him in.
President Trump confirmed Dr. Gottlieb’s resignation, praising him in a tweet for the “terrific job” he has done in this role and commending his efforts to help “us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. ”
Dr. Gottlieb’s legacy may be his work on regulating e-cigarettes, although that work is unfinished. His passion for this subject can be found in a statement made in Nov. 2018, announcing an advanced notice of proposed rule making to regulate e-cigarettes.
“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” Dr. Gottlieb said in the statement.
More recently, the agency announced March 4 enforcement actions aimed at both retailers and manufacturers, including requesting a meeting with Walgreens to discuss the nearly 1,800 violations the chain has amassed across the country for selling tobacco products to minors.
“Because tobacco use is almost always initiated and established during adolescence, early intervention ‒ including making sure tobacco products aren’t being marketed to, sold to, or used by kids ‒ is critical,” he said in announcing the enforcement actions. He added that the FDA will “continue vigorous enforcement activities, with a sustained campaign to monitor, penalize, and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ Internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products. The FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.”
The American Heart Association praised Dr. Gottlieb’s work.
“Commissioner Gottlieb departs the FDA having established himself as a tireless champion of tobacco control,” the organization said in a statement. “He elevated the war on tobacco use – and particularly the epidemic of electronic cigarette use among youth – to unprecedented levels. Because of his efforts, millions more people nationwide are aware of the grave threats posed by e-cigarettes and other tobacco products that are addicting a new generation of youth. We urge the FDA in the strongest possible terms to move forward with effective regulation of an industry that continues to prioritize profits over the lives of consumers.”
Department of Health & Human Services Secretary Alex Azar acknowledged Dr. Gottlieb’s work in combating youth e-cigarette use among a number of areas that the outgoing official has had a positive impact on.
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Secretary Azar said in a statement. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
Under his leadership, FDA has approved a record number of generic drugs, although many still are not on the market yet.
In the area of opioids, his tenure could be a mixed bag as the FDA on the one hand removed an opioid product from the market, but on the other, controversially approved a new, powerful one.
According to reports, he is stepping down to spend more time with his family, who live in Westport, Conn. He splits time between there and Washington. He was confirmed by the Senate in May 2017 with five Democrats and one independent joining Republicans in voting him in.
President Trump confirmed Dr. Gottlieb’s resignation, praising him in a tweet for the “terrific job” he has done in this role and commending his efforts to help “us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. ”
Dr. Gottlieb’s legacy may be his work on regulating e-cigarettes, although that work is unfinished. His passion for this subject can be found in a statement made in Nov. 2018, announcing an advanced notice of proposed rule making to regulate e-cigarettes.
“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” Dr. Gottlieb said in the statement.
More recently, the agency announced March 4 enforcement actions aimed at both retailers and manufacturers, including requesting a meeting with Walgreens to discuss the nearly 1,800 violations the chain has amassed across the country for selling tobacco products to minors.
“Because tobacco use is almost always initiated and established during adolescence, early intervention ‒ including making sure tobacco products aren’t being marketed to, sold to, or used by kids ‒ is critical,” he said in announcing the enforcement actions. He added that the FDA will “continue vigorous enforcement activities, with a sustained campaign to monitor, penalize, and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ Internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products. The FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.”
The American Heart Association praised Dr. Gottlieb’s work.
“Commissioner Gottlieb departs the FDA having established himself as a tireless champion of tobacco control,” the organization said in a statement. “He elevated the war on tobacco use – and particularly the epidemic of electronic cigarette use among youth – to unprecedented levels. Because of his efforts, millions more people nationwide are aware of the grave threats posed by e-cigarettes and other tobacco products that are addicting a new generation of youth. We urge the FDA in the strongest possible terms to move forward with effective regulation of an industry that continues to prioritize profits over the lives of consumers.”
Department of Health & Human Services Secretary Alex Azar acknowledged Dr. Gottlieb’s work in combating youth e-cigarette use among a number of areas that the outgoing official has had a positive impact on.
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Secretary Azar said in a statement. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
Under his leadership, FDA has approved a record number of generic drugs, although many still are not on the market yet.
In the area of opioids, his tenure could be a mixed bag as the FDA on the one hand removed an opioid product from the market, but on the other, controversially approved a new, powerful one.
Take stronger steps to prevent staph infections and sepsis
according to data from a Vital Signs report issued by the Centers for Disease Control and Prevention. The data include both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA).
Although MRSA infections in health care settings declined by approximately 17% during 2005-2012, rates plateaued during 2012-2017, Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference March 5 to present the findings. The report emphasizes the potential for serious illness and death with any staph infection and the need for ongoing vigilance on the part of clinicians, she said.
In addition, community-onset MSSA infections increased by 3.9%/year during 2012-2017. Data from previous studies suggest that this increase may be connected to the opioid epidemic, said Dr. Schuchat.
“People who inject drugs are 16% more likely to develop a staph infection” than are those who don’t inject drugs, she said.
Community-onset MRSA declined by 6.9% during 2001-2016, attributed to declines in health care–associated infections, according to Vital Signs author Athena P. Kourtis, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues. Rates of hospital-associated MSSA infection remained essentially unchanged (P = .11). The overall unadjusted in-hospital mortality among patients with S. aureus bloodstream infections over the study period was 18%.
The data for the report were collected from electronic health records at more than 400 acute care hospitals, as well as population-based surveillance data from the CDC’s Emerging Infections Program.
Most people carry staph on their skin with no ill effects, but the bacteria become dangerous when they enter the bloodstream, Dr. Schuchat emphasized. “We hope the new data today will refocus the nation’s efforts to protect patients from staph infections,” she said.
Dr. Schuchat advised clinicians and hospital administrators to review their data and step up their safety protocols to prevent staph infections. Precautions include wearing gowns and gloves, following proper hand washing protocols, cautious use of antibiotics, and treating infections rapidly when they occur, she said. Dr. Schuchat noted that lack of adherence to these recommendations may have declined in recent years if clinicians and hospital administrators were wondering whether their protocols have an effect and have value. However, “this is a very serious infection, and we think it is very much worth preventing,” she emphasized.
Other strategies to prevent staph infections in health care settings include reviewing infection data regularly, exploring new approaches to prevent infections, and educating patients about when they may be at increased risk for infection, such as when invasive devices are in place or during surgical procedures. Also, clinicians should be aware of the increased risk for patients who inject drugs, Dr. Schuchat said.
Dr. Schuchat commended the Department of Veterans Affairs Medical Centers (VAMC), which overall reduced their rate of staph infections by 43% during the period from 2005 through 2017 in contrast to the national trend. These findings also appeared in the MMWR on March 5. The VAMC implemented additional interventions and increased their adherence to CDC recommendations during this period, she noted.
The Vital Signs data were published March 5 in the CDC’s Morbidity and Mortality Weekly Report; read the full report here.
The CDC researchers had no financial conflicts to disclose.
SOURCE: Kourtis AP et al. MMWR. 2019 Mar 5; 68:1-6.
according to data from a Vital Signs report issued by the Centers for Disease Control and Prevention. The data include both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA).
Although MRSA infections in health care settings declined by approximately 17% during 2005-2012, rates plateaued during 2012-2017, Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference March 5 to present the findings. The report emphasizes the potential for serious illness and death with any staph infection and the need for ongoing vigilance on the part of clinicians, she said.
In addition, community-onset MSSA infections increased by 3.9%/year during 2012-2017. Data from previous studies suggest that this increase may be connected to the opioid epidemic, said Dr. Schuchat.
“People who inject drugs are 16% more likely to develop a staph infection” than are those who don’t inject drugs, she said.
Community-onset MRSA declined by 6.9% during 2001-2016, attributed to declines in health care–associated infections, according to Vital Signs author Athena P. Kourtis, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues. Rates of hospital-associated MSSA infection remained essentially unchanged (P = .11). The overall unadjusted in-hospital mortality among patients with S. aureus bloodstream infections over the study period was 18%.
The data for the report were collected from electronic health records at more than 400 acute care hospitals, as well as population-based surveillance data from the CDC’s Emerging Infections Program.
Most people carry staph on their skin with no ill effects, but the bacteria become dangerous when they enter the bloodstream, Dr. Schuchat emphasized. “We hope the new data today will refocus the nation’s efforts to protect patients from staph infections,” she said.
Dr. Schuchat advised clinicians and hospital administrators to review their data and step up their safety protocols to prevent staph infections. Precautions include wearing gowns and gloves, following proper hand washing protocols, cautious use of antibiotics, and treating infections rapidly when they occur, she said. Dr. Schuchat noted that lack of adherence to these recommendations may have declined in recent years if clinicians and hospital administrators were wondering whether their protocols have an effect and have value. However, “this is a very serious infection, and we think it is very much worth preventing,” she emphasized.
Other strategies to prevent staph infections in health care settings include reviewing infection data regularly, exploring new approaches to prevent infections, and educating patients about when they may be at increased risk for infection, such as when invasive devices are in place or during surgical procedures. Also, clinicians should be aware of the increased risk for patients who inject drugs, Dr. Schuchat said.
Dr. Schuchat commended the Department of Veterans Affairs Medical Centers (VAMC), which overall reduced their rate of staph infections by 43% during the period from 2005 through 2017 in contrast to the national trend. These findings also appeared in the MMWR on March 5. The VAMC implemented additional interventions and increased their adherence to CDC recommendations during this period, she noted.
The Vital Signs data were published March 5 in the CDC’s Morbidity and Mortality Weekly Report; read the full report here.
The CDC researchers had no financial conflicts to disclose.
SOURCE: Kourtis AP et al. MMWR. 2019 Mar 5; 68:1-6.
according to data from a Vital Signs report issued by the Centers for Disease Control and Prevention. The data include both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA).
Although MRSA infections in health care settings declined by approximately 17% during 2005-2012, rates plateaued during 2012-2017, Anne Schuchat, MD, principal deputy director of the CDC, said in a teleconference March 5 to present the findings. The report emphasizes the potential for serious illness and death with any staph infection and the need for ongoing vigilance on the part of clinicians, she said.
In addition, community-onset MSSA infections increased by 3.9%/year during 2012-2017. Data from previous studies suggest that this increase may be connected to the opioid epidemic, said Dr. Schuchat.
“People who inject drugs are 16% more likely to develop a staph infection” than are those who don’t inject drugs, she said.
Community-onset MRSA declined by 6.9% during 2001-2016, attributed to declines in health care–associated infections, according to Vital Signs author Athena P. Kourtis, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and her colleagues. Rates of hospital-associated MSSA infection remained essentially unchanged (P = .11). The overall unadjusted in-hospital mortality among patients with S. aureus bloodstream infections over the study period was 18%.
The data for the report were collected from electronic health records at more than 400 acute care hospitals, as well as population-based surveillance data from the CDC’s Emerging Infections Program.
Most people carry staph on their skin with no ill effects, but the bacteria become dangerous when they enter the bloodstream, Dr. Schuchat emphasized. “We hope the new data today will refocus the nation’s efforts to protect patients from staph infections,” she said.
Dr. Schuchat advised clinicians and hospital administrators to review their data and step up their safety protocols to prevent staph infections. Precautions include wearing gowns and gloves, following proper hand washing protocols, cautious use of antibiotics, and treating infections rapidly when they occur, she said. Dr. Schuchat noted that lack of adherence to these recommendations may have declined in recent years if clinicians and hospital administrators were wondering whether their protocols have an effect and have value. However, “this is a very serious infection, and we think it is very much worth preventing,” she emphasized.
Other strategies to prevent staph infections in health care settings include reviewing infection data regularly, exploring new approaches to prevent infections, and educating patients about when they may be at increased risk for infection, such as when invasive devices are in place or during surgical procedures. Also, clinicians should be aware of the increased risk for patients who inject drugs, Dr. Schuchat said.
Dr. Schuchat commended the Department of Veterans Affairs Medical Centers (VAMC), which overall reduced their rate of staph infections by 43% during the period from 2005 through 2017 in contrast to the national trend. These findings also appeared in the MMWR on March 5. The VAMC implemented additional interventions and increased their adherence to CDC recommendations during this period, she noted.
The Vital Signs data were published March 5 in the CDC’s Morbidity and Mortality Weekly Report; read the full report here.
The CDC researchers had no financial conflicts to disclose.
SOURCE: Kourtis AP et al. MMWR. 2019 Mar 5; 68:1-6.
FROM THE MORBIDITY AND MORTALITY WEEKLY REPORT