FDA statement related to investigational use of Keytruda (pembrolizumab) in multiple myeloma.-Merck Inc.

The FDA has noted that in two clinical trials for an investigational use of the cancer drug Keytruda (pembrolizumab) in combination with two other therapies, Pomalyst (pomalidomide) and Revlimid (lenalidomide) that scientists monitoring the studies found an excess of deaths for patients receiving Keytruda when combined with these other drugs. Trial sponsor Merck and the FDA took immediate action to protect patient safety. Merck stopped enrolling patients into these trials and reported initial concerns to the agency in June 2017. After receiving more information provided by Merck, the FDA acted swiftly in placing a full clinical hold on these trials last month. Patients are no longer receiving treatment with Keytruda in these two trials, which were studying Keytruda for a use that has not been evaluated or approved by the agency.

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. In addition, the agency is working with sponsors of other similar cancer drugs, known as PD-1/PD-L1 inhibitors, to examine other trials in which these drugs are being studied in combination with other drugs, known as immunomodulatory agents, and in which they are being studied in combination with other classes of drugs in hematologic malignancies.

The FDA 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. The FDA reminds 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 and Pomalyst for the treatment of multiple myeloma. The FDA also wants to ensure that patients taking Keytruda and other PD-1/PD-L1 inhibitors know that the FDA still believes the benefits of taking these drugs for their approved uses and as indicated in the labels continue to outweigh their risks. Patients taking these drugs for their approved uses should continue to take their medication as directed by their health care professional.