Janet Woodcock Issues Statement on Safety Concerns Regarding Keytruda

James Radke

Last month, the U.S. Food and Drug Administration (FDA) put clinical holds on 2 studies involving Keytruda (pembrolizumab) in patients with multiple myeloma following an increased number of deaths being reported in those trials.

The clinical trials were: Today, Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER) issued a statement about the hold and to clarify any safety concerns that doctors and patients may have about using Keytruda.

First, Dr. Woodcock noted that Keytruda can still be safely used to treat patients that the drug is currently approved to treat, including: However, a clinical hold is still in place for the 2 clinical trials testing Keytruda in combination with two other therapies.

Dr Woodcock noted that the FDA is actively examining the data from the Keytruda trials and working with the develops of the drug, Merck, to determine the true cause of the safety concerns.

The FDA is also working with sponsors of other PD-1/PD-L1 inhibitors and assessing any safety concerns that have arisen when these drugs are used in combination with immunomodulatory agents.

Dr Woodcock stated that “We are communicating now, given the serious nature of the safety issue, to remind doctors and patients that Keytruda 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.”

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