The U.S. Food and Drug Administration on Tuesday approved Merck’s Keytruda as a first cancer treatment for any solid tumor with a specific genetic feature.
The accelerated approval was for a treatment for patients whose cancers have a specific genetic feature (biomarker). The agency said it was the first time that a cancer treatment based on a common biomarker was approved, rather than on the location in the body where the tumor originated.
Keytruda (pembrolizumab) treats patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
Richard Pazdur, M.D., from FDA said that this is an important first for the cancer community, as until now, the FDA has approved cancer treatments based on where in the body the cancer started—for example, lung or breast cancers. Now, a drug based on a tumor’s biomarker without regard to the tumor’s original location was approved.
Pazdur is acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence.
“The FDA’s approval of this new indication for Keytruda further supports Merck’s commitment to helping people with difficult-to-treat cancers.” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.
Keytruda was approved for this new indication using the Accelerated Approvalpathway, which allows the FDA to approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are could predict benefit to patients. Further study is required to verify and describe expected benefits of Keytruda, and the sponsor is currently conducting these studies in additional patients with MSI-H or dMMR tumors, the FDA said.