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FDA issues safety notification on use of pembrolizumab

Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration is issuing the following statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of pembrolizumab in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.

Pembrolizumab is not approved for treatment of multiple myeloma.

The FDA statement is based on review of data from two clinical trials (KEYNOTE-183 and KEYNOTE-185) evaluating the use of pembrolizumab combined with other treatments in patients with multiple myeloma.

On July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with this drug, because interim results from both trials demonstrated an increased risk of death for patients receiving pembrolizumab when it was combined with an immunomodulatory agent as compared to the control group.

Merck & Co., Inc. was made aware of the issue through an external data monitoring committee recommendation and suspended the trials to enrollment on June 12, 2017.

Janet Woodcock, director of the Center for Drug Evaluation and Research, said "Once the safety issue was discovered, trial sponsor Merck and the FDA took immediate action to protect patient safety. Merck stopped enrolling patients into these trials and reported initial concerns to the agency in June 2017. After receiving more information provided by Merck, the FDA acted swiftly in placing a full clinical hold on these trials last month. Patients are no longer receiving treatment with pembrolizumab in these two trials, which were studying Keytruda for a use that has not been evaluated or approved by the agency."

"The FDA is actively examining the data from the pembrolizumab trials and working directly with Merck to better understand the true cause of the safety concerns. In addition, the agency is working with sponsors of other similar cancer drugs, known as PD-1/PD-L1 inhibitors, to examine other trials in which these drugs are being studied in combination with other drugs, known as immunomodulatory agents, and in which they’re being studied in combination with other classes of drugs in hematologic malignancies. The FDA will take appropriate action as warranted to ensure patients enrolled in these trials are protected and that doctors and clinical trial researchers understand the risks associated with this investigational use."

"We are communicating now, given the serious nature of the safety issue, to remind doctors and patients that pembrolizumab is not approved for the treatment of multiple myeloma and should not be given to patients in combination with any immunomodulatory agents, including Revlimid (lenalidomide) and Pomalyst (pomalidomide), for the treatment of multiple myeloma. We also want to ensure that patients taking pembrolizumab and other PD-1/PD-L1 inhibitors know that the FDA still believes the benefits of taking these drugs for their approved uses and as indicated in the labels continue to outweigh their risks. Patients taking these drugs for their approved uses should continue to take their medication as directed by their health care professional."

The safety and efficacy of using pembrolizumab for approved, on-label uses have been proven.

Patients on pembrolizumab for an approved use should continue to take their medication as directed by their health care professional.

Pembrolizumab is currently approved by the FDA for treatment of:

  • Melanoma
  • Lung Cancer
  • Head and Neck Cancer
  • Classical Hodgkin Lymphoma
  • Urothelial Carcinoma
  • Microsatellite Instability-High (MSI-H) Cancer

Other multiple myeloma clinical trials of pembrolizumab, other PD-1/PD-L1 cancer drugs and other combinations are currently undergoing clinical evaluation.

The FDA will be working directly with sponsors of pembrolizumab and other PD-1/PD-L1 cancer drugs, as well as clinical investigators conducting clinical trials in patients with multiple myeloma, to determine the extent of the safety issue. 

The agency will communicate any new information to the public as soon as it is able.

Health care professionals and consumers are encouraged to report any adverse events or side effects related to the use of these products and other similar products to FDA’s MedWatch Adverse Event Reporting program.

Source: FDA



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