FDA’s CDER Reiterates Safety Risks Associated With Pembrolizumab in Myeloma Trials

The U.S. Food and Drug Administration (FDA) released a statement alerting clinicians and researchers to the risks associated with the investigational use of the PD-1 inhibitor pembrolizumab in patients with myeloma.

In July 2017, the FDA placed holds on two clinical trials for pembrolizumab combination treatment of multiple myeloma after excessive deaths were reported. These trials ended enrollment and patients stopped receiving treatment with pembrolizumab, but the agency released another alert to reiterate the safety concerns associated with pembrolizumab.

“We are communicating now, given the serious nature of the safety issue, to remind doctors and patients that [the agent] is not approved for the treatment of multiple myeloma and should not be given to patients in combination with any immunomodulatory agents, including lenalidomide and pomalidomide, for the treatment of multiple myeloma,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement from the agency.

“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,” Dr. Woodcock said.

While the FDA is actively examining data from the trials and working with the drug’s manufacturer to better understand the cause of the safety concerns, “the FDA still believes the benefits of taking [pembrolizumab and other PD-1/PD-L1 inhibitors] for their approved uses and as indicated in the labels continue to outweigh their risks,” according to the agency’s statement. Dr. Woodcock also stressed that “patients taking these drugs for their approved uses should continue to take their medication as directed by their health-care professional.”

Source: FDA news release, August 31, 2017.

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