Sept. 1 (UPI) — The FDA has placed a full clinical hold on two clinical trials combining the cancer drug Keytruda with other therapies after an excess of deaths was reported.
The agency announced on Thursday that two clinical trials of Keytruda, or pembrolizumab, combined with two other therapies have been halted after the trial sponsor, Merck, stopped enrolling patients into the trials and reported its concerns in June to the FDA.
“Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening disease,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
“But with this hope comes the understanding that there are inherent risks for patients who are willing to participate in this type of research. While much effort is put into early research to ensure that no major safety issues exist before therapies are tested in patients, these trials are ultimately designed to provide vital information about the safety and efficacy of the treatments in people so the FDA can help ensure that the benefits to the intended patients outweigh the risks. When significant safety issues do arise, we must work quickly to prevent further injury or deaths.”
The two clinical trials were evaluating Keytruda for a use that had not been evaluated or approved by the FDA in patients with multiple myeloma.
“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,” Woodcock said.
The FDA approved Keytruda in 2016 for use as a first-line lung cancer treatment alternative to chemotherapy.
Woodcock said she wants to ensure 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 outweigh their risks and patients should continue taking them as directed by their doctor.
