The Food and Drug Administration (FDA) has issued a statement to clinicians and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab; Merck) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of multiple myeloma. Keytruda is currently not FDA-approved to treat patients with multiple myeloma.

Two studies (KEYNOTE-183 and KEYNOTE-185) evaluating Keytruda for this indication were put on full clinical hold by the FDA in July 2017. Interim results from these trials showed an increased risk of death for patients in the Keytruda arm compared to the control group (KEYNOTE-183: hazard ratio [HR] 1.61; KEYNOTE-185: HR 2.06). 

The FDA will continue to monitor outcomes from other multiple myeloma clinical trials of Keytruda (KEYNOTE-023 Cohort 1), other PD-1/PD-L1 cancer drugs and other combinations, and will communicate any new information when it becomes available.

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“The FDA is actively examining the data from the Keytruda trials and working directly with Merck to better understand the true cause of the safety concerns,” said Center for Drug Evaluation and Research Director Janet Woodcock in a press statement. “Today’s alert underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise.”

Patients who are taking Keytruda for approved indications should continue with their treatment. Keytruda is FDA-approved to treat various cancers including melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, and microsatellite instability-high cancer. 

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