May 23 The U.S. Food and Drug Administration on Tuesday approved Merck & Co’s immuno-oncology treatment, Keytruda, for cancer patients who carry a specific genetic feature.
The approval marks the first time the U.S. health regulator has approved a cancer drug based on a biomarker – a biological signal that suggests an increased or decreased risk for a disease.
“Until now, the FDA has approved cancer treatments based on where in the body the cancer started — for example, lung or breast cancers,” said Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.” (bit.ly/2qh8BQd)
Keytruda, which is already approved to treat various cancers, belongs to a new class of drugs, called PD-1 or PD-L1 inhibitors, that block a mechanism tumors use to evade detection by the immune system.
On Tuesday, the FDA approved Keytruda for patients with solid tumors that have been identified as having a biomarker called microsatellite instability-high or mismatch repair deficient.
The approval covers patients whose cancer has progressed despite prior treatment and those who have no satisfactory alternative treatment options. It also includes patients with colorectal cancer whose disease has advanced despite chemotherapy. (Reporting by Natalie Grover in Bengaluru; Editing by Anil D’Silva)