FDA Accelerated Approval for Merck’s Keytruda in Lung Cancer

FDA has granted accelerated approval for Merck’s Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (Alimta) and carboplatin, for first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). The indication was approved based on tumor response rate and progression-free survival. The submission was supported by data from the KEYNOTE-021 study, Cohort G1, in 123 previously untreated patients with metastatic nonsquamous NSCLC that demonstrated an objective response rate (ORR) that was nearly double the ORR of pem/carbo alone (55% compared to 29%, respectively), according to the company.

Merck says that Keytruda is associated with immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. “Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered when appropriate,” it adds.