Safety concerns have halted investigational use of Keytruda

In a statement from Janet Woodcock, director of the Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), it has been revealed that the investigational use of Keytruda (pembrolizumab) has been halted due to safety concerns.

The cancer drug was being evaluated in two clinical trials for an investigational use in combination with two other therapies. Scientists monitoring the clinical trials raised safety concerns over an excess of deaths in those receiving Keytruda when combined with the other drugs.

“As is required in these scenarios, once the safety issue was discovered, trial sponsor Merck and the FDA took immediate action to protect patient safety,” explained Woodcock. “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.”

Both the FDA and Merck are working together to confirm the true cause of the safety concerns with Keytruda. Additionally, the FDA has announced it will work with other sponsors of similar trials evaluating PD-1/PD-L1 inhibitors in combination with other drugs to ensure patient safety and that the risks associated with these investigational use therapies are understood by the doctors and clinical trial researchers.

“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,” added Woodcock.

“We also want 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 healthcare professional.”