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September 2, 2017 – The American Food & Drug Administration (FDA) has announced that two clinical trials with Pembrolizumab (Keytruda) in patients with multiple myeloma have been put on hold. The FDA informs the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Pembrolizumab (Keytruda) in combination with dexamethasone and an immunomodulatory agent (Lenalidomide (Revlimid) or Pomalidomide (Pomalyst)) for the treatment of patients with multiple myeloma. Pembrolizumab (Keytruda) is not approved for treatment of multiple myeloma.
The FDA’s action is based on review of data from two clinical trials (KEYNOTE-183 and KEYNOTE-185) evaluating the use of Pembrolizumab (Keytruda) 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 (Keytruda) when it was combined with an immunomodulatory agent as compared to the control group (see statistical analysis section below). The sponsor of these trials, 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.
The present FDA action does not apply to patients taking Pembrolizumab (Keytruda) for any of the approved indication. Pembrolizumab (Keytruda) is currently approved by the FDA for treatment of: Melanoma, Lung Cancer, Head and Neck Cancer, Classical Hodgkin Lymphoma, Urothelial Carcinoma, and Microsatellite Instability-High (MSI-H) Cancer. Patients taking Pembrolizumab (Keytruda) for any of these approved indications should continue to take their medication as directed by their health care professional.
Also of note: Other multiple myeloma clinical trials of Pembrolizumab (Keytruda), 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 (Keytruda) 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 to.
Also of note and very important in this context: Health care professionals and patients 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 directly at www.fda.gov/MedWatch/report. by sending / faxing in the downloable form, or by calling 001-800-332-1088. In other parts of the world, health care professionals and patients should report to their local agencies, or directly the sponsors of the pharmaceutical products concerned.
For additional information, read the MedWatch safety alert at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574347.htm, and for a summary of the statistical analysis and findings, please refer to the FDA Statement.