FDA warns about deaths in cancer drug trials

An increased risk of deaths for patients in clinical trials receiving pembrolizumab (Keytruda, Merck) and 2 other drugs led FDA to stop the clinical trials and warn healthcare professionals and patients.

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In 2 clinical trials for an investigational use of the cancer drug Keytruda in combination with the 2 iummunomodulatory lenalidomide (Revlimid) and pomalidomide (Pomalyst), researchers found an excess of deaths for patients receiving Keytruda when combined with the other drugs.

The patients were being treated for multiple myeloma; Keytruda is not approved for the treatment of that cancer.

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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,” wrote Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, on the agency’s web site.

The agency is also examining other similar clinical trials and “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,” Woodcock wrote.

“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 (pomalidomid).

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