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FDA approves PARP inhibitor for BRCA+ advanced breast cancer
The Food and Drug Administration has approved the PARP inhibitor olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy.
This is the first PARP inhibitor approved to treat breast cancer and the first approval for treatment of patients with metastatic breast cancer who have a BRCA gene mutation, the FDA said in a press statement.
The FDA also expanded approval of the companion diagnostic, BRACAnalysis CDx, to include the detection of BRCA mutations in blood samples from patients with breast cancer.
A capsule form of olaparib (Lynparza) was first approved in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. In August 2017, the FDA granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network, the FDA said.
Approval for the treatment of breast cancer was based on a 2.8 month improvement in progression-free survival with olaparib vs standard chemotherapy in the phase 3 OlympiAD trial of 302 previously treated patients with BRCA-positive, HER2-negative breast cancer. Results of the trial were presented at ASCO 2017 and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2017 Jun 4. doi: 10.1056/NEJMoa1706450).
Common side effects of olaparib include anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, nasopharyngitis, respiratory tract infection, influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis.
Severe side effects include development of myelodysplastic syndrome/acute myeloid leukemia and pneumonitis. Women should be advised of the potential risk to the fetus and to use effective contraception, the FDA said.
The FDA granted the approval of olaparib to AstraZeneca Pharmaceuticals LP and the approval of the BRACAnalysis CDx to Myriad Genetic Laboratories, Inc.
The Food and Drug Administration has approved the PARP inhibitor olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy.
This is the first PARP inhibitor approved to treat breast cancer and the first approval for treatment of patients with metastatic breast cancer who have a BRCA gene mutation, the FDA said in a press statement.
The FDA also expanded approval of the companion diagnostic, BRACAnalysis CDx, to include the detection of BRCA mutations in blood samples from patients with breast cancer.
A capsule form of olaparib (Lynparza) was first approved in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. In August 2017, the FDA granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network, the FDA said.
Approval for the treatment of breast cancer was based on a 2.8 month improvement in progression-free survival with olaparib vs standard chemotherapy in the phase 3 OlympiAD trial of 302 previously treated patients with BRCA-positive, HER2-negative breast cancer. Results of the trial were presented at ASCO 2017 and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2017 Jun 4. doi: 10.1056/NEJMoa1706450).
Common side effects of olaparib include anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, nasopharyngitis, respiratory tract infection, influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis.
Severe side effects include development of myelodysplastic syndrome/acute myeloid leukemia and pneumonitis. Women should be advised of the potential risk to the fetus and to use effective contraception, the FDA said.
The FDA granted the approval of olaparib to AstraZeneca Pharmaceuticals LP and the approval of the BRACAnalysis CDx to Myriad Genetic Laboratories, Inc.
The Food and Drug Administration has approved the PARP inhibitor olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy.
This is the first PARP inhibitor approved to treat breast cancer and the first approval for treatment of patients with metastatic breast cancer who have a BRCA gene mutation, the FDA said in a press statement.
The FDA also expanded approval of the companion diagnostic, BRACAnalysis CDx, to include the detection of BRCA mutations in blood samples from patients with breast cancer.
A capsule form of olaparib (Lynparza) was first approved in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. In August 2017, the FDA granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network, the FDA said.
Approval for the treatment of breast cancer was based on a 2.8 month improvement in progression-free survival with olaparib vs standard chemotherapy in the phase 3 OlympiAD trial of 302 previously treated patients with BRCA-positive, HER2-negative breast cancer. Results of the trial were presented at ASCO 2017 and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2017 Jun 4. doi: 10.1056/NEJMoa1706450).
Common side effects of olaparib include anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, nasopharyngitis, respiratory tract infection, influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis.
Severe side effects include development of myelodysplastic syndrome/acute myeloid leukemia and pneumonitis. Women should be advised of the potential risk to the fetus and to use effective contraception, the FDA said.
The FDA granted the approval of olaparib to AstraZeneca Pharmaceuticals LP and the approval of the BRACAnalysis CDx to Myriad Genetic Laboratories, Inc.
FDA: No more codeine or hydrocodone cold medicines for children
New safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone limit their use to adults 18 years or older.
The Food and Drug Administration took this action after “conducting an extensive review and convening a panel of outside experts,” which determined that the risks of these medicines outweigh their benefits in children younger than 18 years. The agency also is requiring companies to add a boxed warning to drug labels for prescription cough and cold medicines containing codeine or hydrocodone about the “risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing,” according to an FDA safety announcement.
Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath, and headache, according to the press release.
Reassure parents that cough because of a cold or upper respiratory infection is self-limited and generally does not need to be treated, the FDA advised. If children do need cough treatment, there are over-the-counter products such as dextromethorphan, as well as prescription benzonatate products, the FDA said. Encourage parents to check labels of nonprescription cough and cold products.
In a few states, some codeine cough medicines are available OTC. The FDA is considering regulatory action for these products, according to the safety announcement.
New safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone limit their use to adults 18 years or older.
The Food and Drug Administration took this action after “conducting an extensive review and convening a panel of outside experts,” which determined that the risks of these medicines outweigh their benefits in children younger than 18 years. The agency also is requiring companies to add a boxed warning to drug labels for prescription cough and cold medicines containing codeine or hydrocodone about the “risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing,” according to an FDA safety announcement.
Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath, and headache, according to the press release.
Reassure parents that cough because of a cold or upper respiratory infection is self-limited and generally does not need to be treated, the FDA advised. If children do need cough treatment, there are over-the-counter products such as dextromethorphan, as well as prescription benzonatate products, the FDA said. Encourage parents to check labels of nonprescription cough and cold products.
In a few states, some codeine cough medicines are available OTC. The FDA is considering regulatory action for these products, according to the safety announcement.
New safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone limit their use to adults 18 years or older.
The Food and Drug Administration took this action after “conducting an extensive review and convening a panel of outside experts,” which determined that the risks of these medicines outweigh their benefits in children younger than 18 years. The agency also is requiring companies to add a boxed warning to drug labels for prescription cough and cold medicines containing codeine or hydrocodone about the “risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing,” according to an FDA safety announcement.
Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath, and headache, according to the press release.
Reassure parents that cough because of a cold or upper respiratory infection is self-limited and generally does not need to be treated, the FDA advised. If children do need cough treatment, there are over-the-counter products such as dextromethorphan, as well as prescription benzonatate products, the FDA said. Encourage parents to check labels of nonprescription cough and cold products.
In a few states, some codeine cough medicines are available OTC. The FDA is considering regulatory action for these products, according to the safety announcement.
Disparities persist in infant safe sleep practices
Sleep-related deaths among infants in the United States decreased during the 1990s as a result of recommendations to place babies on their backs to sleep. However, the decline has leveled off in recent years, and health care providers should proactively counsel caregivers about safe sleep practices, wrote Jennifer M. Bombard, MSPH, of the Centers for Disease Control and Prevention and her colleagues in a study published online in the Morbidity and Mortality Weekly Report.
Overall, 22% of respondents from 32 states and New York City in 2015 reported placing babies in a position other than their backs to sleep. In addition, 61% of respondents from 14 states reported bed sharing, and 39% from 13 states and New York City reported using soft bedding, including bumper pads and thick blankets.
Unsafe sleep practices varied by maternal demographics; nonsupine sleep positioning was more likely among non-Hispanic blacks, individuals aged 25 years or younger, those with 12 years or less of education, and those participating in the Special Supplemental Nutrition Program for Women, Infants, and Children.
“These findings highlight the need to implement and evaluate interventions to continue improving safe sleep practices,” Ms. Bombard and her associates said.
They cited the Study of Attitudes and Factors Effecting Infant Care Practices, in which caregivers who received appropriate advice on safe sleep practices were significantly less likely to place infants in a nonsupine position to sleep. “Evidence-based approaches to increase use of safe sleep practices include developing health messages and educational tools for caregivers and educating health and child care professionals on safe sleep practices,” they noted.
The study was limited by several factors, including reliance on self reports and inclusion of only states with Pregnancy Risk Assessment Monitoring System records, the researchers said.
Ms. Bombard and her associates had no relevant financial disclosures.
pdnews@frontlinemedcom.com
SOURCE: Bombard J et al. MMWR. 2018 Jan 9. doi: 10.15585/mmwr.mm6701e1.
Sleep-related deaths among infants in the United States decreased during the 1990s as a result of recommendations to place babies on their backs to sleep. However, the decline has leveled off in recent years, and health care providers should proactively counsel caregivers about safe sleep practices, wrote Jennifer M. Bombard, MSPH, of the Centers for Disease Control and Prevention and her colleagues in a study published online in the Morbidity and Mortality Weekly Report.
Overall, 22% of respondents from 32 states and New York City in 2015 reported placing babies in a position other than their backs to sleep. In addition, 61% of respondents from 14 states reported bed sharing, and 39% from 13 states and New York City reported using soft bedding, including bumper pads and thick blankets.
Unsafe sleep practices varied by maternal demographics; nonsupine sleep positioning was more likely among non-Hispanic blacks, individuals aged 25 years or younger, those with 12 years or less of education, and those participating in the Special Supplemental Nutrition Program for Women, Infants, and Children.
“These findings highlight the need to implement and evaluate interventions to continue improving safe sleep practices,” Ms. Bombard and her associates said.
They cited the Study of Attitudes and Factors Effecting Infant Care Practices, in which caregivers who received appropriate advice on safe sleep practices were significantly less likely to place infants in a nonsupine position to sleep. “Evidence-based approaches to increase use of safe sleep practices include developing health messages and educational tools for caregivers and educating health and child care professionals on safe sleep practices,” they noted.
The study was limited by several factors, including reliance on self reports and inclusion of only states with Pregnancy Risk Assessment Monitoring System records, the researchers said.
Ms. Bombard and her associates had no relevant financial disclosures.
pdnews@frontlinemedcom.com
SOURCE: Bombard J et al. MMWR. 2018 Jan 9. doi: 10.15585/mmwr.mm6701e1.
Sleep-related deaths among infants in the United States decreased during the 1990s as a result of recommendations to place babies on their backs to sleep. However, the decline has leveled off in recent years, and health care providers should proactively counsel caregivers about safe sleep practices, wrote Jennifer M. Bombard, MSPH, of the Centers for Disease Control and Prevention and her colleagues in a study published online in the Morbidity and Mortality Weekly Report.
Overall, 22% of respondents from 32 states and New York City in 2015 reported placing babies in a position other than their backs to sleep. In addition, 61% of respondents from 14 states reported bed sharing, and 39% from 13 states and New York City reported using soft bedding, including bumper pads and thick blankets.
Unsafe sleep practices varied by maternal demographics; nonsupine sleep positioning was more likely among non-Hispanic blacks, individuals aged 25 years or younger, those with 12 years or less of education, and those participating in the Special Supplemental Nutrition Program for Women, Infants, and Children.
“These findings highlight the need to implement and evaluate interventions to continue improving safe sleep practices,” Ms. Bombard and her associates said.
They cited the Study of Attitudes and Factors Effecting Infant Care Practices, in which caregivers who received appropriate advice on safe sleep practices were significantly less likely to place infants in a nonsupine position to sleep. “Evidence-based approaches to increase use of safe sleep practices include developing health messages and educational tools for caregivers and educating health and child care professionals on safe sleep practices,” they noted.
The study was limited by several factors, including reliance on self reports and inclusion of only states with Pregnancy Risk Assessment Monitoring System records, the researchers said.
Ms. Bombard and her associates had no relevant financial disclosures.
pdnews@frontlinemedcom.com
SOURCE: Bombard J et al. MMWR. 2018 Jan 9. doi: 10.15585/mmwr.mm6701e1.
FROM MMWR
Key clinical point: Health care providers can improve safe sleep for babies by counseling caregivers.
Major finding: Of respondents from 32 states and New York City in 2015, 22% reported placing babies in a position other than their backs to sleep.
Study details: The data come from the 2009-2015 Pregnancy Risk Assessment Monitoring System.
Disclosures: The researchers had no relevant financial disclosures.
Source: Bombard J et al. MMWR 2018 Jan 9. doi: 10.15585/mmwr.mm6701e1.
FDA cites manufacturer of autologous stem cells for regulatory, manufacturing missteps
for manufacturing processes that may compromise its safety and for failing to toe the regulatory line in marketing.
American CryoStem received an FDA warning letter Jan. 3 demanding that the company comply with best-manufacturing processes and obtain an investigational new drug application if it wishes to continue marketing ATCELL for its currently advertised clinical indications and administration routes. These include intravenous, intrathecal, or aerosol inhalation of the product for anoxic brain injury, Parkinson’s disease, amyotrophic lateral sclerosis, stroke, and multiple sclerosis.
“Please be advised that, to lawfully market a drug that is a biological product, a valid biologics license must be in effect,” noted the letter. “Such licenses are issued only after a showing that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations. ATCELL is not the subject of an approved biologics license application nor is there an IND in effect. Based on this information, we have determined that your actions have violated the Food, Drug, and Cosmetic Act and the Public Health Service Act.”
FDA inspectors conducted a site inspection of American CryoStem in Eatontown, N.J., last summer, during which they “documented evidence of significant deviations from current good manufacturing practice.” The agency then provided the company a chance to respond to these issues. The new warning letter discussed each complaint, noting that some were inadequately addressed, and demanded that the company take action within 15 working days or face potential legal process, including seizure and/or injunction.
American CryoStem is one of the first companies to experience increased scrutiny under FDA’s new commitment to regulate the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
The new policy is designed to support the potential of cellular rejuvenation medicine, while protecting patients from “unscrupulous actors” who might endanger public health with untested products, according to FDA Commissioner Scott Gottlieb, MD. As enthusiasm for stem cell treatments surges, so are reports of adverse events. The New England Journal of Medicine recently reported on three patients with age-related macular degeneration who were blinded by intravitreal injection of autologous adipose-derived stem cells (N Engl J Med. 2017;376:1047-53).
Under the new policy, cell- and tissue-based products could be exempt from FDA premarket review only if they are removed from and implanted back into the same patient in their original form, or if the products are “minimally manipulated.” ATCELL fulfills neither qualification, the FDA warning letter said.
“You process adipose tissue ... to isolate cellular components of adipose tissue, commonly referred to as stromal vascular fraction [SVF]. Such processing is more than minimal manipulation because [it alters] the original relevant characteristics of the [tissue] relating to its utility for reconstruction, repair, or replacement. Then you process the SVF by expanding it in cell culture to manufacture ATCELL. Such expansion also is more than minimal manipulation because it alters the original relevant characteristics of the tissue.”
Furthermore, the letter noted, at least one of the components used in the clonal expansion process is investigational and not intended for human use. The manufacturer of that component, which was not named, “indicates the following: ‘Unless otherwise stated in our catalog or other company documentation accompanying the product(s), our products are intended for research use only and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to human and animals.”
The FDA also took exception with several equipment and lab safety issues. ATCELL was being created in areas that had no clean space designation – a serious concern, the letter said.
“American CryoStem’s unvalidated processes, inadequately controlled environment, lack of control of components used in production, and lack of sufficient and validated product testing ... pose a significant risk that ATCELL may be contaminated with microorganisms or have other serious product quality defects ... Because the product is administered to humans by various higher risk routes of administration, including intravenously, intrathecally, and by aerosol inhalation, if contaminated, its use could cause a range of adverse events, from infections to death.”
FDA also expressed concerns over a lack of consistent quality control testing of each batch and questioned whether the company’s method of shipping ATCELL to clinicians had been adequately validated.
Finally, the agency raised concerns that ATCELL, while it is labeled as being for research purposes only, may harm patients indirectly by preventing them from seeking timely treatment with proven therapies.
“ATCELL is intended to treat a variety of serious or life-threatening diseases or conditions, all of which are non-homologous uses,” the warning letter noted. “Such uses raise potential significant safety concerns because there is less basis on which to predict the product’s behavior in the recipient, and use of these unapproved products may cause users to delay or discontinue medical treatments that have been found safe and effective.”
SOURCE: FDA warning letter
for manufacturing processes that may compromise its safety and for failing to toe the regulatory line in marketing.
American CryoStem received an FDA warning letter Jan. 3 demanding that the company comply with best-manufacturing processes and obtain an investigational new drug application if it wishes to continue marketing ATCELL for its currently advertised clinical indications and administration routes. These include intravenous, intrathecal, or aerosol inhalation of the product for anoxic brain injury, Parkinson’s disease, amyotrophic lateral sclerosis, stroke, and multiple sclerosis.
“Please be advised that, to lawfully market a drug that is a biological product, a valid biologics license must be in effect,” noted the letter. “Such licenses are issued only after a showing that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations. ATCELL is not the subject of an approved biologics license application nor is there an IND in effect. Based on this information, we have determined that your actions have violated the Food, Drug, and Cosmetic Act and the Public Health Service Act.”
FDA inspectors conducted a site inspection of American CryoStem in Eatontown, N.J., last summer, during which they “documented evidence of significant deviations from current good manufacturing practice.” The agency then provided the company a chance to respond to these issues. The new warning letter discussed each complaint, noting that some were inadequately addressed, and demanded that the company take action within 15 working days or face potential legal process, including seizure and/or injunction.
American CryoStem is one of the first companies to experience increased scrutiny under FDA’s new commitment to regulate the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
The new policy is designed to support the potential of cellular rejuvenation medicine, while protecting patients from “unscrupulous actors” who might endanger public health with untested products, according to FDA Commissioner Scott Gottlieb, MD. As enthusiasm for stem cell treatments surges, so are reports of adverse events. The New England Journal of Medicine recently reported on three patients with age-related macular degeneration who were blinded by intravitreal injection of autologous adipose-derived stem cells (N Engl J Med. 2017;376:1047-53).
Under the new policy, cell- and tissue-based products could be exempt from FDA premarket review only if they are removed from and implanted back into the same patient in their original form, or if the products are “minimally manipulated.” ATCELL fulfills neither qualification, the FDA warning letter said.
“You process adipose tissue ... to isolate cellular components of adipose tissue, commonly referred to as stromal vascular fraction [SVF]. Such processing is more than minimal manipulation because [it alters] the original relevant characteristics of the [tissue] relating to its utility for reconstruction, repair, or replacement. Then you process the SVF by expanding it in cell culture to manufacture ATCELL. Such expansion also is more than minimal manipulation because it alters the original relevant characteristics of the tissue.”
Furthermore, the letter noted, at least one of the components used in the clonal expansion process is investigational and not intended for human use. The manufacturer of that component, which was not named, “indicates the following: ‘Unless otherwise stated in our catalog or other company documentation accompanying the product(s), our products are intended for research use only and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to human and animals.”
The FDA also took exception with several equipment and lab safety issues. ATCELL was being created in areas that had no clean space designation – a serious concern, the letter said.
“American CryoStem’s unvalidated processes, inadequately controlled environment, lack of control of components used in production, and lack of sufficient and validated product testing ... pose a significant risk that ATCELL may be contaminated with microorganisms or have other serious product quality defects ... Because the product is administered to humans by various higher risk routes of administration, including intravenously, intrathecally, and by aerosol inhalation, if contaminated, its use could cause a range of adverse events, from infections to death.”
FDA also expressed concerns over a lack of consistent quality control testing of each batch and questioned whether the company’s method of shipping ATCELL to clinicians had been adequately validated.
Finally, the agency raised concerns that ATCELL, while it is labeled as being for research purposes only, may harm patients indirectly by preventing them from seeking timely treatment with proven therapies.
“ATCELL is intended to treat a variety of serious or life-threatening diseases or conditions, all of which are non-homologous uses,” the warning letter noted. “Such uses raise potential significant safety concerns because there is less basis on which to predict the product’s behavior in the recipient, and use of these unapproved products may cause users to delay or discontinue medical treatments that have been found safe and effective.”
SOURCE: FDA warning letter
for manufacturing processes that may compromise its safety and for failing to toe the regulatory line in marketing.
American CryoStem received an FDA warning letter Jan. 3 demanding that the company comply with best-manufacturing processes and obtain an investigational new drug application if it wishes to continue marketing ATCELL for its currently advertised clinical indications and administration routes. These include intravenous, intrathecal, or aerosol inhalation of the product for anoxic brain injury, Parkinson’s disease, amyotrophic lateral sclerosis, stroke, and multiple sclerosis.
“Please be advised that, to lawfully market a drug that is a biological product, a valid biologics license must be in effect,” noted the letter. “Such licenses are issued only after a showing that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations. ATCELL is not the subject of an approved biologics license application nor is there an IND in effect. Based on this information, we have determined that your actions have violated the Food, Drug, and Cosmetic Act and the Public Health Service Act.”
FDA inspectors conducted a site inspection of American CryoStem in Eatontown, N.J., last summer, during which they “documented evidence of significant deviations from current good manufacturing practice.” The agency then provided the company a chance to respond to these issues. The new warning letter discussed each complaint, noting that some were inadequately addressed, and demanded that the company take action within 15 working days or face potential legal process, including seizure and/or injunction.
American CryoStem is one of the first companies to experience increased scrutiny under FDA’s new commitment to regulate the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
The new policy is designed to support the potential of cellular rejuvenation medicine, while protecting patients from “unscrupulous actors” who might endanger public health with untested products, according to FDA Commissioner Scott Gottlieb, MD. As enthusiasm for stem cell treatments surges, so are reports of adverse events. The New England Journal of Medicine recently reported on three patients with age-related macular degeneration who were blinded by intravitreal injection of autologous adipose-derived stem cells (N Engl J Med. 2017;376:1047-53).
Under the new policy, cell- and tissue-based products could be exempt from FDA premarket review only if they are removed from and implanted back into the same patient in their original form, or if the products are “minimally manipulated.” ATCELL fulfills neither qualification, the FDA warning letter said.
“You process adipose tissue ... to isolate cellular components of adipose tissue, commonly referred to as stromal vascular fraction [SVF]. Such processing is more than minimal manipulation because [it alters] the original relevant characteristics of the [tissue] relating to its utility for reconstruction, repair, or replacement. Then you process the SVF by expanding it in cell culture to manufacture ATCELL. Such expansion also is more than minimal manipulation because it alters the original relevant characteristics of the tissue.”
Furthermore, the letter noted, at least one of the components used in the clonal expansion process is investigational and not intended for human use. The manufacturer of that component, which was not named, “indicates the following: ‘Unless otherwise stated in our catalog or other company documentation accompanying the product(s), our products are intended for research use only and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to human and animals.”
The FDA also took exception with several equipment and lab safety issues. ATCELL was being created in areas that had no clean space designation – a serious concern, the letter said.
“American CryoStem’s unvalidated processes, inadequately controlled environment, lack of control of components used in production, and lack of sufficient and validated product testing ... pose a significant risk that ATCELL may be contaminated with microorganisms or have other serious product quality defects ... Because the product is administered to humans by various higher risk routes of administration, including intravenously, intrathecally, and by aerosol inhalation, if contaminated, its use could cause a range of adverse events, from infections to death.”
FDA also expressed concerns over a lack of consistent quality control testing of each batch and questioned whether the company’s method of shipping ATCELL to clinicians had been adequately validated.
Finally, the agency raised concerns that ATCELL, while it is labeled as being for research purposes only, may harm patients indirectly by preventing them from seeking timely treatment with proven therapies.
“ATCELL is intended to treat a variety of serious or life-threatening diseases or conditions, all of which are non-homologous uses,” the warning letter noted. “Such uses raise potential significant safety concerns because there is less basis on which to predict the product’s behavior in the recipient, and use of these unapproved products may cause users to delay or discontinue medical treatments that have been found safe and effective.”
SOURCE: FDA warning letter
Denosumab indication now includes multiple myeloma, Amgen announces
The Food and Drug Administration has expanded the indications for denosumab (Xgeva), previously indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, to include patients with multiple myeloma, according to a press release from Amgen, the manufacturer of Xgeva.
“Up to 40% of [multiple myeloma] patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis. Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option,” Dr. Noopur Raje, director of the Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, said in the press release.
Adverse events in multiple myeloma patients were broadly similar to the known safety profile of denosumab. The most common adverse events were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common adverse event resulting in discontinuation of treatment was osteonecrosis of the jaw.
Find the full press release on the Amgen website.
The Food and Drug Administration has expanded the indications for denosumab (Xgeva), previously indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, to include patients with multiple myeloma, according to a press release from Amgen, the manufacturer of Xgeva.
“Up to 40% of [multiple myeloma] patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis. Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option,” Dr. Noopur Raje, director of the Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, said in the press release.
Adverse events in multiple myeloma patients were broadly similar to the known safety profile of denosumab. The most common adverse events were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common adverse event resulting in discontinuation of treatment was osteonecrosis of the jaw.
Find the full press release on the Amgen website.
The Food and Drug Administration has expanded the indications for denosumab (Xgeva), previously indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, to include patients with multiple myeloma, according to a press release from Amgen, the manufacturer of Xgeva.
“Up to 40% of [multiple myeloma] patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis. Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option,” Dr. Noopur Raje, director of the Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, said in the press release.
Adverse events in multiple myeloma patients were broadly similar to the known safety profile of denosumab. The most common adverse events were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common adverse event resulting in discontinuation of treatment was osteonecrosis of the jaw.
Find the full press release on the Amgen website.
FDA grants breakthrough therapy designation for severe aplastic anemia drug
The Food and Drug Administration has granted breakthrough therapy designation to eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia (SAA).
Eltrombopag already is approved as a second-line therapy in patients with refractory SAA and is approved for adults and children with refractory chronic immune thrombocytopenia (ITP).
“Promacta is a promising medicine that, if approved for first-line use in severe aplastic anemia, may redefine the standard of care for patients with this rare and serious bone marrow condition,” Samit Hirawat, MD, head of Novartis Oncology Global Drug Development, said in a statement.
The Food and Drug Administration has granted breakthrough therapy designation to eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia (SAA).
Eltrombopag already is approved as a second-line therapy in patients with refractory SAA and is approved for adults and children with refractory chronic immune thrombocytopenia (ITP).
“Promacta is a promising medicine that, if approved for first-line use in severe aplastic anemia, may redefine the standard of care for patients with this rare and serious bone marrow condition,” Samit Hirawat, MD, head of Novartis Oncology Global Drug Development, said in a statement.
The Food and Drug Administration has granted breakthrough therapy designation to eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia (SAA).
Eltrombopag already is approved as a second-line therapy in patients with refractory SAA and is approved for adults and children with refractory chronic immune thrombocytopenia (ITP).
“Promacta is a promising medicine that, if approved for first-line use in severe aplastic anemia, may redefine the standard of care for patients with this rare and serious bone marrow condition,” Samit Hirawat, MD, head of Novartis Oncology Global Drug Development, said in a statement.
FDA expands indication for bosutinib in newly diagnosed CML
Bosutinib is now approved for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML).
The Food and Drug Administration granted accelerated approval for bosutinib (Bosulif), which is marketed by Pfizer. The approval is based on data from the randomized, multicenter phase 3 BFORE trial of 487 patients with Ph+ newly diagnosed chronic phase CML who received either bosutinib or imatinib 400 mg once daily. Major molecular response at 12 months was 47.2% (95% confidence interval, 40.9-53.4) in the bosutinib arm and 36.9% (95% CI, 30.8-43.0) in the imatinib arm (two-sided P = .0200).
Bosutinib, a kinase inhibitor, was first approved in September 2012 for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.
The recommended dose of bosutinib for newly diagnosed chronic phase Ph+ CML is 400 mg orally once daily with food.
The most common adverse reactions to the drug in newly diagnosed CML patients are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.
Bosutinib is now approved for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML).
The Food and Drug Administration granted accelerated approval for bosutinib (Bosulif), which is marketed by Pfizer. The approval is based on data from the randomized, multicenter phase 3 BFORE trial of 487 patients with Ph+ newly diagnosed chronic phase CML who received either bosutinib or imatinib 400 mg once daily. Major molecular response at 12 months was 47.2% (95% confidence interval, 40.9-53.4) in the bosutinib arm and 36.9% (95% CI, 30.8-43.0) in the imatinib arm (two-sided P = .0200).
Bosutinib, a kinase inhibitor, was first approved in September 2012 for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.
The recommended dose of bosutinib for newly diagnosed chronic phase Ph+ CML is 400 mg orally once daily with food.
The most common adverse reactions to the drug in newly diagnosed CML patients are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.
Bosutinib is now approved for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML).
The Food and Drug Administration granted accelerated approval for bosutinib (Bosulif), which is marketed by Pfizer. The approval is based on data from the randomized, multicenter phase 3 BFORE trial of 487 patients with Ph+ newly diagnosed chronic phase CML who received either bosutinib or imatinib 400 mg once daily. Major molecular response at 12 months was 47.2% (95% confidence interval, 40.9-53.4) in the bosutinib arm and 36.9% (95% CI, 30.8-43.0) in the imatinib arm (two-sided P = .0200).
Bosutinib, a kinase inhibitor, was first approved in September 2012 for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.
The recommended dose of bosutinib for newly diagnosed chronic phase Ph+ CML is 400 mg orally once daily with food.
The most common adverse reactions to the drug in newly diagnosed CML patients are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.
FDA bans 24 ingredients from OTC health care antiseptic products
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
Pertuzumab approved for HER2-positive breast cancer
, according to the Food and Drug Administration.
The approval was based on results from the APHINITY trial, which included 4,804 patients who had HER2-positive early breast cancers that were excised prior to the study. After a median follow-up period of 45.4 months, an invasive disease event occurred in 7.1% of all patients who received pertuzumab (Perjeta) and in 8.7% of patients who received placebo. In patients with hormone receptor–negative disease, invasive events occurred in 8.2% of the pertuzumab group and in 10.6% of the placebo group. In patients with node-positive disease, the invasive event rate was 9.2% in the pertuzumab group and 12.1% in the placebo group.
“The initial pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30- to 60-minute intravenous infusion,” the FDA said in the statement.
Find the full statement on the FDA website.
, according to the Food and Drug Administration.
The approval was based on results from the APHINITY trial, which included 4,804 patients who had HER2-positive early breast cancers that were excised prior to the study. After a median follow-up period of 45.4 months, an invasive disease event occurred in 7.1% of all patients who received pertuzumab (Perjeta) and in 8.7% of patients who received placebo. In patients with hormone receptor–negative disease, invasive events occurred in 8.2% of the pertuzumab group and in 10.6% of the placebo group. In patients with node-positive disease, the invasive event rate was 9.2% in the pertuzumab group and 12.1% in the placebo group.
“The initial pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30- to 60-minute intravenous infusion,” the FDA said in the statement.
Find the full statement on the FDA website.
, according to the Food and Drug Administration.
The approval was based on results from the APHINITY trial, which included 4,804 patients who had HER2-positive early breast cancers that were excised prior to the study. After a median follow-up period of 45.4 months, an invasive disease event occurred in 7.1% of all patients who received pertuzumab (Perjeta) and in 8.7% of patients who received placebo. In patients with hormone receptor–negative disease, invasive events occurred in 8.2% of the pertuzumab group and in 10.6% of the placebo group. In patients with node-positive disease, the invasive event rate was 9.2% in the pertuzumab group and 12.1% in the placebo group.
“The initial pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30- to 60-minute intravenous infusion,” the FDA said in the statement.
Find the full statement on the FDA website.
FDA expands approval of nivolumab for melanoma treatment
The Food and Drug Administration has approved nivolumab for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection.
Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma, the FDA said in a press statement.
Approval was based on results from the CHECKMATE-238 trial, where 906 patients with completely resected stage IIIB/C or stage IV melanoma received either nivolumab or ipilimumab for up to 1 year. Recurrence-free survival was superior in patients who received nivolumab, with 34% of patients in the nivolumab group experiencing recurrence/death, compared to 45.5% in the ipilimumab group.
The recommended dose and schedule of nivolumab in adjuvant melanoma is 240 mg administered as an IV infusion over 60 minutes every 2 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year, according to the FDA.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb Company.
Find the full press release on the FDA website.
The Food and Drug Administration has approved nivolumab for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection.
Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma, the FDA said in a press statement.
Approval was based on results from the CHECKMATE-238 trial, where 906 patients with completely resected stage IIIB/C or stage IV melanoma received either nivolumab or ipilimumab for up to 1 year. Recurrence-free survival was superior in patients who received nivolumab, with 34% of patients in the nivolumab group experiencing recurrence/death, compared to 45.5% in the ipilimumab group.
The recommended dose and schedule of nivolumab in adjuvant melanoma is 240 mg administered as an IV infusion over 60 minutes every 2 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year, according to the FDA.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb Company.
Find the full press release on the FDA website.
The Food and Drug Administration has approved nivolumab for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection.
Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma, the FDA said in a press statement.
Approval was based on results from the CHECKMATE-238 trial, where 906 patients with completely resected stage IIIB/C or stage IV melanoma received either nivolumab or ipilimumab for up to 1 year. Recurrence-free survival was superior in patients who received nivolumab, with 34% of patients in the nivolumab group experiencing recurrence/death, compared to 45.5% in the ipilimumab group.
The recommended dose and schedule of nivolumab in adjuvant melanoma is 240 mg administered as an IV infusion over 60 minutes every 2 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year, according to the FDA.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb Company.
Find the full press release on the FDA website.