FDA Puts Out Alert on Halted Merck & Co. Trials for Keytruda

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FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.

On Aug. 31, 2017, FDA issued a statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with using Keytruda (pembrolizumab), Merck & Co.’s anti-cancer biologic, in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for treating multiple myeloma. Keytruda is currently not approved for treating multiple myeloma, according to FDA in a press release.

The agency issued the statement based on data from two recently halted clinical trials. FDA required the discontinuation of the two trials on July 3, 2017 because interim results from both trials demonstrated an increased risk of death for patients receiving Keytruda in combination with an immunomodulatory agent, as compared to the control group. Keytruda, initially approved by FDA in September 2014 for treating unresectable or metastatic melanoma, is a blockbuster product for Merck with 2016 sales of $1.4 billion.

Merck, which had been notified of the issue through an external data monitoring committee, had earlier suspended the trials to enrollment on June 12, 2017. Other studies of Keytruda, however, continue unchanged, Merck said in a company press release.

FDA’s statement does not apply to patients taking Keytruda for an approved indication. Keytruda’s currently approved indications include treatment of melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, and microsatellite instability-high cancer.


Other multiple myeloma clinical trials of Keytruda, other programmed death (PD)-1/PD-L1 cancer drugs and other combinations are currently undergoing clinical evaluation. FDA will be working directly with sponsors of Keytruda and other PD-1/PD-L1 cancer drugs and clinical investigators conducting clinical trials in patients with multiple myeloma to determine the extent of the safety issue.

Source: FDA and Merck & Co.