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FDA approves second CAR-T therapy
A second chimeric antigen receptor (CAR) T-cell therapy has gained FDA approval, this time for the treatment of large B-cell lymphoma in adults.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “This approval demonstrates the continued momentum of this promising new area of medicine, and we’re committed to supporting and helping expedite the development of these products.”
Approval was based on ZUMA-1, a multicenter clinical trial of 101 adults with refractory or relapsed large B-cell lymphoma. Almost three-quarters (72%) of patients responded, including 51% who achieved complete remission.
CAR-T therapy can cause severe, life-threatening side effects, most notably cytokine release syndrome (CRS) and neurologic toxicities, for which axicabtagene ciloleucel will carry a boxed warning and will come with a risk evaluation and mitigation strategy (REMS), according to the FDA.
The list price for a single treatment of axicabtagene ciloleucel is $373,000, according to the manufacturer.
“We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine,” Dr. Gottlieb said in a statement. “That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”
Axicabtagene ciloleucel was developed by Kite Pharma, which was acquired recently by Gilead Sciences.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
A second chimeric antigen receptor (CAR) T-cell therapy has gained FDA approval, this time for the treatment of large B-cell lymphoma in adults.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “This approval demonstrates the continued momentum of this promising new area of medicine, and we’re committed to supporting and helping expedite the development of these products.”
Approval was based on ZUMA-1, a multicenter clinical trial of 101 adults with refractory or relapsed large B-cell lymphoma. Almost three-quarters (72%) of patients responded, including 51% who achieved complete remission.
CAR-T therapy can cause severe, life-threatening side effects, most notably cytokine release syndrome (CRS) and neurologic toxicities, for which axicabtagene ciloleucel will carry a boxed warning and will come with a risk evaluation and mitigation strategy (REMS), according to the FDA.
The list price for a single treatment of axicabtagene ciloleucel is $373,000, according to the manufacturer.
“We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine,” Dr. Gottlieb said in a statement. “That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”
Axicabtagene ciloleucel was developed by Kite Pharma, which was acquired recently by Gilead Sciences.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
A second chimeric antigen receptor (CAR) T-cell therapy has gained FDA approval, this time for the treatment of large B-cell lymphoma in adults.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “This approval demonstrates the continued momentum of this promising new area of medicine, and we’re committed to supporting and helping expedite the development of these products.”
Approval was based on ZUMA-1, a multicenter clinical trial of 101 adults with refractory or relapsed large B-cell lymphoma. Almost three-quarters (72%) of patients responded, including 51% who achieved complete remission.
CAR-T therapy can cause severe, life-threatening side effects, most notably cytokine release syndrome (CRS) and neurologic toxicities, for which axicabtagene ciloleucel will carry a boxed warning and will come with a risk evaluation and mitigation strategy (REMS), according to the FDA.
The list price for a single treatment of axicabtagene ciloleucel is $373,000, according to the manufacturer.
“We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine,” Dr. Gottlieb said in a statement. “That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”
Axicabtagene ciloleucel was developed by Kite Pharma, which was acquired recently by Gilead Sciences.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
CDC data show decline in some hospital-acquired infections
SAN DIEGO – There was an encouraging 22% reduction in hospital-acquired infections (HAIs) after adjustment for clinical variables when 2015 and 2011 data from national Centers for Disease Control and Prevention hospital surveys were compared.
“The data suggest that national efforts toward preventing HAIs are succeeding,” reported Shelley S. Magill, MD, PhD, a medical epidemiologist in the Division of Healthcare Quality Promotion at the CDC who summarized the data at an annual scientific meeting on infectious diseases .
The comparative data were drawn from point prevalence surveys conducted in 2011 and 2015 as part of the CDC’s Emerging Infections Program. In this type of survey, the data are collected over 1 day, providing a snapshot in time among selected hospitals. The analysis presented by Dr. Magill was restricted to the 148 hospitals that participated in both the 2011 and 2015 surveys, although the 2015 survey included a total of 199 hospitals, of which other data analyses are planned.
Due to the change in incidence, the rank order of HAIs was different in 2015 relative to 2011. While surgical site infections (SSIs) represented the most frequent HAI in 2011, they fell to the third most frequent HAI in 2015; pneumonia and gastrointestinal (GI) infections assumed the first and second spots, respectively. The GI HAI infection category includes Clostridium difficile infection.
The incidence of SSI HAI among all hospitalized patients in the survey fell by 41% between 2011 and 2015 (from 1.00% to 0.59%; P = .001). The other big contributor to the overall reduction in HAIs was the fall in the incidence of urinary tract infections, which fell 36% (from 0.55% to 0.35%; P = .04). The decrease in pneumonia (from 0.97% to 0.89%) was not significant, nor was the even more modest reduction in bloodstream HAI (from 0.45% to 0.43%). There was a modest increase in GI/Clostridium difficile infections (from 0.56% to 0.59%).
The surveys do not permit the reduction in HAI rates to be attributed to any specific prevention practices, but Dr. Magill pointed out that the overall reductions correlate with reduced use of urinary catheters and central lines; reductions of both have been advocated as a means for improved infection control. Of several factors that might contribute to a reduction in SSI HAI, Dr. Magill speculated that better adherence to guidelines and more rigorous steps at preoperative infection control strategies might be among them.
Detailed analyses of the data collected from all of the hospitals that participated in the 2015 survey are planned, including an evaluation of which antibiotics were used to treat the HAIs found in this survey. Although the findings so far encourage speculation that infection control practices, such as prudent use of urinary catheters, are having a positive effect, Dr. Magill said that the data also point out the challenges.
“Given that pneumonia continues to represent a large proportion of HAIs in hospitals, more work is needed to identify risk factors; understand the factors that are preventable, particularly in the nonventilated patients; and develop better preventive approaches,” Dr. Magill said.
Dr. Magill reported no financial relationships relevant to this study.
SAN DIEGO – There was an encouraging 22% reduction in hospital-acquired infections (HAIs) after adjustment for clinical variables when 2015 and 2011 data from national Centers for Disease Control and Prevention hospital surveys were compared.
“The data suggest that national efforts toward preventing HAIs are succeeding,” reported Shelley S. Magill, MD, PhD, a medical epidemiologist in the Division of Healthcare Quality Promotion at the CDC who summarized the data at an annual scientific meeting on infectious diseases .
The comparative data were drawn from point prevalence surveys conducted in 2011 and 2015 as part of the CDC’s Emerging Infections Program. In this type of survey, the data are collected over 1 day, providing a snapshot in time among selected hospitals. The analysis presented by Dr. Magill was restricted to the 148 hospitals that participated in both the 2011 and 2015 surveys, although the 2015 survey included a total of 199 hospitals, of which other data analyses are planned.
Due to the change in incidence, the rank order of HAIs was different in 2015 relative to 2011. While surgical site infections (SSIs) represented the most frequent HAI in 2011, they fell to the third most frequent HAI in 2015; pneumonia and gastrointestinal (GI) infections assumed the first and second spots, respectively. The GI HAI infection category includes Clostridium difficile infection.
The incidence of SSI HAI among all hospitalized patients in the survey fell by 41% between 2011 and 2015 (from 1.00% to 0.59%; P = .001). The other big contributor to the overall reduction in HAIs was the fall in the incidence of urinary tract infections, which fell 36% (from 0.55% to 0.35%; P = .04). The decrease in pneumonia (from 0.97% to 0.89%) was not significant, nor was the even more modest reduction in bloodstream HAI (from 0.45% to 0.43%). There was a modest increase in GI/Clostridium difficile infections (from 0.56% to 0.59%).
The surveys do not permit the reduction in HAI rates to be attributed to any specific prevention practices, but Dr. Magill pointed out that the overall reductions correlate with reduced use of urinary catheters and central lines; reductions of both have been advocated as a means for improved infection control. Of several factors that might contribute to a reduction in SSI HAI, Dr. Magill speculated that better adherence to guidelines and more rigorous steps at preoperative infection control strategies might be among them.
Detailed analyses of the data collected from all of the hospitals that participated in the 2015 survey are planned, including an evaluation of which antibiotics were used to treat the HAIs found in this survey. Although the findings so far encourage speculation that infection control practices, such as prudent use of urinary catheters, are having a positive effect, Dr. Magill said that the data also point out the challenges.
“Given that pneumonia continues to represent a large proportion of HAIs in hospitals, more work is needed to identify risk factors; understand the factors that are preventable, particularly in the nonventilated patients; and develop better preventive approaches,” Dr. Magill said.
Dr. Magill reported no financial relationships relevant to this study.
SAN DIEGO – There was an encouraging 22% reduction in hospital-acquired infections (HAIs) after adjustment for clinical variables when 2015 and 2011 data from national Centers for Disease Control and Prevention hospital surveys were compared.
“The data suggest that national efforts toward preventing HAIs are succeeding,” reported Shelley S. Magill, MD, PhD, a medical epidemiologist in the Division of Healthcare Quality Promotion at the CDC who summarized the data at an annual scientific meeting on infectious diseases .
The comparative data were drawn from point prevalence surveys conducted in 2011 and 2015 as part of the CDC’s Emerging Infections Program. In this type of survey, the data are collected over 1 day, providing a snapshot in time among selected hospitals. The analysis presented by Dr. Magill was restricted to the 148 hospitals that participated in both the 2011 and 2015 surveys, although the 2015 survey included a total of 199 hospitals, of which other data analyses are planned.
Due to the change in incidence, the rank order of HAIs was different in 2015 relative to 2011. While surgical site infections (SSIs) represented the most frequent HAI in 2011, they fell to the third most frequent HAI in 2015; pneumonia and gastrointestinal (GI) infections assumed the first and second spots, respectively. The GI HAI infection category includes Clostridium difficile infection.
The incidence of SSI HAI among all hospitalized patients in the survey fell by 41% between 2011 and 2015 (from 1.00% to 0.59%; P = .001). The other big contributor to the overall reduction in HAIs was the fall in the incidence of urinary tract infections, which fell 36% (from 0.55% to 0.35%; P = .04). The decrease in pneumonia (from 0.97% to 0.89%) was not significant, nor was the even more modest reduction in bloodstream HAI (from 0.45% to 0.43%). There was a modest increase in GI/Clostridium difficile infections (from 0.56% to 0.59%).
The surveys do not permit the reduction in HAI rates to be attributed to any specific prevention practices, but Dr. Magill pointed out that the overall reductions correlate with reduced use of urinary catheters and central lines; reductions of both have been advocated as a means for improved infection control. Of several factors that might contribute to a reduction in SSI HAI, Dr. Magill speculated that better adherence to guidelines and more rigorous steps at preoperative infection control strategies might be among them.
Detailed analyses of the data collected from all of the hospitals that participated in the 2015 survey are planned, including an evaluation of which antibiotics were used to treat the HAIs found in this survey. Although the findings so far encourage speculation that infection control practices, such as prudent use of urinary catheters, are having a positive effect, Dr. Magill said that the data also point out the challenges.
“Given that pneumonia continues to represent a large proportion of HAIs in hospitals, more work is needed to identify risk factors; understand the factors that are preventable, particularly in the nonventilated patients; and develop better preventive approaches,” Dr. Magill said.
Dr. Magill reported no financial relationships relevant to this study.
AT ID WEEK 2017
Key clinical point:
Major finding: In two point prevalence surveys conducted in the same hospitals, the rate of HAI was 22% lower in 2015 (P = .001), compared with 2011.
Data source: CDC national surveys of HAIs in 148 hospitals in two different years (2011 and 2015) were compared.
Disclosures: Dr. Magill reported no financial relationships relevant to this study.
Biologic approved for moderate to severe psoriasis in adolescents
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
FDA approves first extended-release steroid injection for OA knee pain
Flexion Therapeutics announced Oct. 6 the approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) as the first and only extended-release, intra-articular injection for osteoarthritis knee pain.
Zilretta uses a proprietary microsphere-based formulation of triamcinolone acetonide to provide pain relief over 12 weeks by prolonging the release of triamcinolone acetonide inside the synovial fluid. The approval is based on data from a phase 3 clinical trial. The randomized, double-blind study enrolled 484 patients at 37 centers worldwide. The label also includes the results from a double-blind, randomized, parallel-group trial, which examined blood glucose concentrations in patients with type 2 diabetes to show how Zilretta can avoid blood glucose spikes observed with corticosteroid use.
Zilretta is expected to be available in the United States by the end of October.
Flexion Therapeutics announced Oct. 6 the approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) as the first and only extended-release, intra-articular injection for osteoarthritis knee pain.
Zilretta uses a proprietary microsphere-based formulation of triamcinolone acetonide to provide pain relief over 12 weeks by prolonging the release of triamcinolone acetonide inside the synovial fluid. The approval is based on data from a phase 3 clinical trial. The randomized, double-blind study enrolled 484 patients at 37 centers worldwide. The label also includes the results from a double-blind, randomized, parallel-group trial, which examined blood glucose concentrations in patients with type 2 diabetes to show how Zilretta can avoid blood glucose spikes observed with corticosteroid use.
Zilretta is expected to be available in the United States by the end of October.
Flexion Therapeutics announced Oct. 6 the approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) as the first and only extended-release, intra-articular injection for osteoarthritis knee pain.
Zilretta uses a proprietary microsphere-based formulation of triamcinolone acetonide to provide pain relief over 12 weeks by prolonging the release of triamcinolone acetonide inside the synovial fluid. The approval is based on data from a phase 3 clinical trial. The randomized, double-blind study enrolled 484 patients at 37 centers worldwide. The label also includes the results from a double-blind, randomized, parallel-group trial, which examined blood glucose concentrations in patients with type 2 diabetes to show how Zilretta can avoid blood glucose spikes observed with corticosteroid use.
Zilretta is expected to be available in the United States by the end of October.
Nearly 80% of health care personnel stepped up for flu shots
Nearly four out of five health care personnel in the United States received a flu vaccination during the 2016-2017 flu season, but a majority of those working in long-term care settings were not vaccinated, based on data from an Internet survey of more than 2,000 individuals that was conducted by the Centers for Disease Control and Prevention.
A total of 78.6% of the survey’s respondents said they’d been vaccinated during the 2016-2017 season. Vaccination coverage for health care personnel overall has remained in the 77%-79% range in recent years, but that represents an increase from 64% in 2010-2011.
“As in previous seasons, the highest coverage was among HCP whose workplace had vaccination requirements,” noted Carla L. Black, PhD, of the CDC, and colleagues (MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66[38]:1009-15). The researchers reviewed data collected from an Internet panel survey of 2,438 health care personnel between March 28, 2017, and April 19, 2017.
Physicians boasted the highest vaccination coverage in 2016-2017 (96%), followed by pharmacists (94%), nurses (93%), nurse practitioners and physician assistants (92%), other clinical providers (80%), nonclinical health care providers (74%), and aides and assistants (69%).
Flu vaccination rates were highest among HCPs working in a hospital setting (92%); 94% of survey respondents in hospitals reported either having a vaccination requirement at work or being provided at least 1 day of on-site vaccination.
Vaccination rates were lowest among health care personnel in long-term care settings (68%), where only 26% reported a workplace vaccination requirement. However, vaccination rates in long-term care rose to 90% when employers required vaccination.
The report’s findings were limited by several factors, including the use of a volunteer sample, the reliance on self-reports, and the potential differences between Internet survey results and population-based estimates of flu vaccination.
However, “in the absence of vaccination requirements, the findings in this study support the recommendations found in the Guide to Community Preventive Services, which include active promotion of on-site vaccination at no cost or low cost to increase influenza vaccination coverage among HCPs,” the researchers said.
The researchers had no financial conflicts to disclose.
Nearly four out of five health care personnel in the United States received a flu vaccination during the 2016-2017 flu season, but a majority of those working in long-term care settings were not vaccinated, based on data from an Internet survey of more than 2,000 individuals that was conducted by the Centers for Disease Control and Prevention.
A total of 78.6% of the survey’s respondents said they’d been vaccinated during the 2016-2017 season. Vaccination coverage for health care personnel overall has remained in the 77%-79% range in recent years, but that represents an increase from 64% in 2010-2011.
“As in previous seasons, the highest coverage was among HCP whose workplace had vaccination requirements,” noted Carla L. Black, PhD, of the CDC, and colleagues (MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66[38]:1009-15). The researchers reviewed data collected from an Internet panel survey of 2,438 health care personnel between March 28, 2017, and April 19, 2017.
Physicians boasted the highest vaccination coverage in 2016-2017 (96%), followed by pharmacists (94%), nurses (93%), nurse practitioners and physician assistants (92%), other clinical providers (80%), nonclinical health care providers (74%), and aides and assistants (69%).
Flu vaccination rates were highest among HCPs working in a hospital setting (92%); 94% of survey respondents in hospitals reported either having a vaccination requirement at work or being provided at least 1 day of on-site vaccination.
Vaccination rates were lowest among health care personnel in long-term care settings (68%), where only 26% reported a workplace vaccination requirement. However, vaccination rates in long-term care rose to 90% when employers required vaccination.
The report’s findings were limited by several factors, including the use of a volunteer sample, the reliance on self-reports, and the potential differences between Internet survey results and population-based estimates of flu vaccination.
However, “in the absence of vaccination requirements, the findings in this study support the recommendations found in the Guide to Community Preventive Services, which include active promotion of on-site vaccination at no cost or low cost to increase influenza vaccination coverage among HCPs,” the researchers said.
The researchers had no financial conflicts to disclose.
Nearly four out of five health care personnel in the United States received a flu vaccination during the 2016-2017 flu season, but a majority of those working in long-term care settings were not vaccinated, based on data from an Internet survey of more than 2,000 individuals that was conducted by the Centers for Disease Control and Prevention.
A total of 78.6% of the survey’s respondents said they’d been vaccinated during the 2016-2017 season. Vaccination coverage for health care personnel overall has remained in the 77%-79% range in recent years, but that represents an increase from 64% in 2010-2011.
“As in previous seasons, the highest coverage was among HCP whose workplace had vaccination requirements,” noted Carla L. Black, PhD, of the CDC, and colleagues (MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66[38]:1009-15). The researchers reviewed data collected from an Internet panel survey of 2,438 health care personnel between March 28, 2017, and April 19, 2017.
Physicians boasted the highest vaccination coverage in 2016-2017 (96%), followed by pharmacists (94%), nurses (93%), nurse practitioners and physician assistants (92%), other clinical providers (80%), nonclinical health care providers (74%), and aides and assistants (69%).
Flu vaccination rates were highest among HCPs working in a hospital setting (92%); 94% of survey respondents in hospitals reported either having a vaccination requirement at work or being provided at least 1 day of on-site vaccination.
Vaccination rates were lowest among health care personnel in long-term care settings (68%), where only 26% reported a workplace vaccination requirement. However, vaccination rates in long-term care rose to 90% when employers required vaccination.
The report’s findings were limited by several factors, including the use of a volunteer sample, the reliance on self-reports, and the potential differences between Internet survey results and population-based estimates of flu vaccination.
However, “in the absence of vaccination requirements, the findings in this study support the recommendations found in the Guide to Community Preventive Services, which include active promotion of on-site vaccination at no cost or low cost to increase influenza vaccination coverage among HCPs,” the researchers said.
The researchers had no financial conflicts to disclose.
FROM MMWR
Key clinical point:
Major finding: Overall flu vaccination coverage among U.S. health care personnel was 78.6% in the 2016-2017 season
Data source: The data come from an Internet survey of 2,438 health care personnel.
Disclosures: The researchers had no financial conflicts to disclose.
FDA approves test to screen donated blood for Zika virus
The cobas Zika test has been approved for detecting the virus in whole blood, blood components, and donated organs, the U.S. Food and Drug Administration announced in a press release.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply.”
In August 2016, the FDA issued a final guidance document recommending that all individual units of whole blood and blood components be screened with an investigational blood screening test available under an investigational new drug application. Data obtained on the cobas Zika test under its investigational new drug application and from additional studies performed by the manufacturer demonstrated that the cobas Zika test is effective. Testing individual samples from blood donations at five external laboratory sites resulted in a clinical specificity exceeding 99%.
The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems.
The cobas Zika test has been approved for detecting the virus in whole blood, blood components, and donated organs, the U.S. Food and Drug Administration announced in a press release.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply.”
In August 2016, the FDA issued a final guidance document recommending that all individual units of whole blood and blood components be screened with an investigational blood screening test available under an investigational new drug application. Data obtained on the cobas Zika test under its investigational new drug application and from additional studies performed by the manufacturer demonstrated that the cobas Zika test is effective. Testing individual samples from blood donations at five external laboratory sites resulted in a clinical specificity exceeding 99%.
The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems.
The cobas Zika test has been approved for detecting the virus in whole blood, blood components, and donated organs, the U.S. Food and Drug Administration announced in a press release.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply.”
In August 2016, the FDA issued a final guidance document recommending that all individual units of whole blood and blood components be screened with an investigational blood screening test available under an investigational new drug application. Data obtained on the cobas Zika test under its investigational new drug application and from additional studies performed by the manufacturer demonstrated that the cobas Zika test is effective. Testing individual samples from blood donations at five external laboratory sites resulted in a clinical specificity exceeding 99%.
The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems.
FDA approves third indication for onabotulinumtoxinA
The Food and Drug Administration has approved onabotulinumtoxinA, marketed as Botox Cosmetic by Allergan, for a third indication: the temporary improvement in the appearance of “moderate to severe forehead lines associated with frontalis muscle activity” in adults, according to the manufacturer.
The company announced the latest approval in a press release on October 3.
The Food and Drug Administration has approved onabotulinumtoxinA, marketed as Botox Cosmetic by Allergan, for a third indication: the temporary improvement in the appearance of “moderate to severe forehead lines associated with frontalis muscle activity” in adults, according to the manufacturer.
The company announced the latest approval in a press release on October 3.
The Food and Drug Administration has approved onabotulinumtoxinA, marketed as Botox Cosmetic by Allergan, for a third indication: the temporary improvement in the appearance of “moderate to severe forehead lines associated with frontalis muscle activity” in adults, according to the manufacturer.
The company announced the latest approval in a press release on October 3.
FDA approves higher dose brigatinib tablet for advanced ALK+ NSCLC
The Food and Drug Administration has approved 180 mg brigatinib (Alunbrig) tablets for treatment of anaplastic lymphoma kinase–positive (ALK+) metastatic non–small cell lung cancer (NSCLC), expanding on previously available 30-mg tablets.*
“With the approval of a 180-mg tablet, Alunbrig has become the only ALK inhibitor available as a one tablet per day dose that can be taken with or without food,” Ryan Cohlhepp, PharmD, vice president, U.S. Commercial, at Takeda Oncology said in a press release.
Approval of the regimen was based on objective response in the ongoing, two-arm, open-label, multicenter phase 2 ALTA trial, which enrolled 222 patients with metastatic or locally advanced ALK+ NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily or 180 mg once daily following a 7-day lead-in at 90 mg once daily. Of those in the 180-mg arm, 53% had an objective response, compared with 48% in the 90-mg arm.
Adverse reactions occurred in 40% of the patients in the 180-mg arm, compared with 38% in the 90-mg arm. The most common serious adverse reactions were pneumonia and interstitial lung disease/pneumonitis. Fatal adverse reactions occurred in 3.7% of the patients, caused by pneumonia (two patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (one patient each).
The ALTA trial is ongoing, and updated results will be presented at the World Conference on Lung Cancer in Yokohama, Japan, on Oct. 15-18, the company said in the press release.
*Correction, 10/4/17: An earlier version of this article misstated the previously available tablet sizes.
The Food and Drug Administration has approved 180 mg brigatinib (Alunbrig) tablets for treatment of anaplastic lymphoma kinase–positive (ALK+) metastatic non–small cell lung cancer (NSCLC), expanding on previously available 30-mg tablets.*
“With the approval of a 180-mg tablet, Alunbrig has become the only ALK inhibitor available as a one tablet per day dose that can be taken with or without food,” Ryan Cohlhepp, PharmD, vice president, U.S. Commercial, at Takeda Oncology said in a press release.
Approval of the regimen was based on objective response in the ongoing, two-arm, open-label, multicenter phase 2 ALTA trial, which enrolled 222 patients with metastatic or locally advanced ALK+ NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily or 180 mg once daily following a 7-day lead-in at 90 mg once daily. Of those in the 180-mg arm, 53% had an objective response, compared with 48% in the 90-mg arm.
Adverse reactions occurred in 40% of the patients in the 180-mg arm, compared with 38% in the 90-mg arm. The most common serious adverse reactions were pneumonia and interstitial lung disease/pneumonitis. Fatal adverse reactions occurred in 3.7% of the patients, caused by pneumonia (two patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (one patient each).
The ALTA trial is ongoing, and updated results will be presented at the World Conference on Lung Cancer in Yokohama, Japan, on Oct. 15-18, the company said in the press release.
*Correction, 10/4/17: An earlier version of this article misstated the previously available tablet sizes.
The Food and Drug Administration has approved 180 mg brigatinib (Alunbrig) tablets for treatment of anaplastic lymphoma kinase–positive (ALK+) metastatic non–small cell lung cancer (NSCLC), expanding on previously available 30-mg tablets.*
“With the approval of a 180-mg tablet, Alunbrig has become the only ALK inhibitor available as a one tablet per day dose that can be taken with or without food,” Ryan Cohlhepp, PharmD, vice president, U.S. Commercial, at Takeda Oncology said in a press release.
Approval of the regimen was based on objective response in the ongoing, two-arm, open-label, multicenter phase 2 ALTA trial, which enrolled 222 patients with metastatic or locally advanced ALK+ NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily or 180 mg once daily following a 7-day lead-in at 90 mg once daily. Of those in the 180-mg arm, 53% had an objective response, compared with 48% in the 90-mg arm.
Adverse reactions occurred in 40% of the patients in the 180-mg arm, compared with 38% in the 90-mg arm. The most common serious adverse reactions were pneumonia and interstitial lung disease/pneumonitis. Fatal adverse reactions occurred in 3.7% of the patients, caused by pneumonia (two patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (one patient each).
The ALTA trial is ongoing, and updated results will be presented at the World Conference on Lung Cancer in Yokohama, Japan, on Oct. 15-18, the company said in the press release.
*Correction, 10/4/17: An earlier version of this article misstated the previously available tablet sizes.
Zika: CDC begins transition from emergency to long-term response
Officials at the Centers for Disease Control and Prevention are deactivating their emergency operations related to the Zika virus, the agency announced Sept. 29.
The Zika Coordination and Operations Transition Team will instead shift the CDC’s efforts toward long-term activities, including continued support for physicians counseling pregnant women and advice on follow-up care for infants.
Data from the agency show that while there was a steady stream of possible Zika cases reported among pregnant women in the summer of 2017 – about 100 cases every 2 weeks – the numbers were lower than in 2016, when the infection hit its peak. Overall, during 2015-2017, there have been a total of 2,197 cases of possible Zika infection among pregnant women reported in U.S. states and 4,504 in U.S. territories. During that same time period, there have been 98 liveborn infants with birth defects in the U.S. states and 138 in the U.S. territories.
CDC activated the Emergency Operations Center in January 2016 in response to reports on the impact of Zika virus infection in pregnancy, including cases of microcephaly.
“Deactivation does not mean that the threat of Zika has lessened in importance or that people are no longer at risk of infection,” CDC officials said in a statement. “Zika continues to be a public health threat in the United States and internationally. Zika is still a risk for pregnant women, and the continental United States and Hawaii will continue to see some travel-related cases as travelers visit countries and territories with risk of Zika transmission.”
mschneider@frontlinemedcom.com
On Twitter @maryellenny
Officials at the Centers for Disease Control and Prevention are deactivating their emergency operations related to the Zika virus, the agency announced Sept. 29.
The Zika Coordination and Operations Transition Team will instead shift the CDC’s efforts toward long-term activities, including continued support for physicians counseling pregnant women and advice on follow-up care for infants.
Data from the agency show that while there was a steady stream of possible Zika cases reported among pregnant women in the summer of 2017 – about 100 cases every 2 weeks – the numbers were lower than in 2016, when the infection hit its peak. Overall, during 2015-2017, there have been a total of 2,197 cases of possible Zika infection among pregnant women reported in U.S. states and 4,504 in U.S. territories. During that same time period, there have been 98 liveborn infants with birth defects in the U.S. states and 138 in the U.S. territories.
CDC activated the Emergency Operations Center in January 2016 in response to reports on the impact of Zika virus infection in pregnancy, including cases of microcephaly.
“Deactivation does not mean that the threat of Zika has lessened in importance or that people are no longer at risk of infection,” CDC officials said in a statement. “Zika continues to be a public health threat in the United States and internationally. Zika is still a risk for pregnant women, and the continental United States and Hawaii will continue to see some travel-related cases as travelers visit countries and territories with risk of Zika transmission.”
mschneider@frontlinemedcom.com
On Twitter @maryellenny
Officials at the Centers for Disease Control and Prevention are deactivating their emergency operations related to the Zika virus, the agency announced Sept. 29.
The Zika Coordination and Operations Transition Team will instead shift the CDC’s efforts toward long-term activities, including continued support for physicians counseling pregnant women and advice on follow-up care for infants.
Data from the agency show that while there was a steady stream of possible Zika cases reported among pregnant women in the summer of 2017 – about 100 cases every 2 weeks – the numbers were lower than in 2016, when the infection hit its peak. Overall, during 2015-2017, there have been a total of 2,197 cases of possible Zika infection among pregnant women reported in U.S. states and 4,504 in U.S. territories. During that same time period, there have been 98 liveborn infants with birth defects in the U.S. states and 138 in the U.S. territories.
CDC activated the Emergency Operations Center in January 2016 in response to reports on the impact of Zika virus infection in pregnancy, including cases of microcephaly.
“Deactivation does not mean that the threat of Zika has lessened in importance or that people are no longer at risk of infection,” CDC officials said in a statement. “Zika continues to be a public health threat in the United States and internationally. Zika is still a risk for pregnant women, and the continental United States and Hawaii will continue to see some travel-related cases as travelers visit countries and territories with risk of Zika transmission.”
mschneider@frontlinemedcom.com
On Twitter @maryellenny
FDA approves abemaciclib for advanced breast cancer
The Food and Drug Administration has approved abemaciclib (Verzenio) to be given in combination with fulvestrant, to treat patients who have hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy.
This is the third cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved for the treatment of advanced breast cancer. Palbociclib (Ibrance) was granted accelerated approval in February 2015, in combination with letrozole, for the treatment of HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women. Ribociclib (Kisqali) was approved in March 2017, in combination with any aromatase inhibitor, also for the treatment of HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women.
Approval of abemaciclib in combination with fulvestrant was based on a median progression-free survival of 16.4 months for patients taking abemaciclib with fulvestrant, compared with 9.3 months for patients taking a placebo with fulvestrant, in a randomized trial. All 669 patients in the trial had HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and had not received chemotherapy once the cancer had metastasized.
Approval of abemaciclib as a single agent was based on an overall response rate of 19.7% in a single-arm trial of 132 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasized.
Common side effects of abemaciclib include diarrhea, neutropenia, leukopenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting, and headache.
Serious side effects include diarrhea, neutropenia, elevated liver blood tests, and deep venous thrombosis/pulmonary embolism, the FDA said.
Approval was granted to Eli Lilly.
The Food and Drug Administration has approved abemaciclib (Verzenio) to be given in combination with fulvestrant, to treat patients who have hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy.
This is the third cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved for the treatment of advanced breast cancer. Palbociclib (Ibrance) was granted accelerated approval in February 2015, in combination with letrozole, for the treatment of HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women. Ribociclib (Kisqali) was approved in March 2017, in combination with any aromatase inhibitor, also for the treatment of HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women.
Approval of abemaciclib in combination with fulvestrant was based on a median progression-free survival of 16.4 months for patients taking abemaciclib with fulvestrant, compared with 9.3 months for patients taking a placebo with fulvestrant, in a randomized trial. All 669 patients in the trial had HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and had not received chemotherapy once the cancer had metastasized.
Approval of abemaciclib as a single agent was based on an overall response rate of 19.7% in a single-arm trial of 132 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasized.
Common side effects of abemaciclib include diarrhea, neutropenia, leukopenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting, and headache.
Serious side effects include diarrhea, neutropenia, elevated liver blood tests, and deep venous thrombosis/pulmonary embolism, the FDA said.
Approval was granted to Eli Lilly.
The Food and Drug Administration has approved abemaciclib (Verzenio) to be given in combination with fulvestrant, to treat patients who have hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy.
This is the third cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved for the treatment of advanced breast cancer. Palbociclib (Ibrance) was granted accelerated approval in February 2015, in combination with letrozole, for the treatment of HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women. Ribociclib (Kisqali) was approved in March 2017, in combination with any aromatase inhibitor, also for the treatment of HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women.
Approval of abemaciclib in combination with fulvestrant was based on a median progression-free survival of 16.4 months for patients taking abemaciclib with fulvestrant, compared with 9.3 months for patients taking a placebo with fulvestrant, in a randomized trial. All 669 patients in the trial had HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and had not received chemotherapy once the cancer had metastasized.
Approval of abemaciclib as a single agent was based on an overall response rate of 19.7% in a single-arm trial of 132 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasized.
Common side effects of abemaciclib include diarrhea, neutropenia, leukopenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting, and headache.
Serious side effects include diarrhea, neutropenia, elevated liver blood tests, and deep venous thrombosis/pulmonary embolism, the FDA said.
Approval was granted to Eli Lilly.