FDA Green Lights Keytruda as the First Anti-PD-1 Immunotherapy in First-Line NSCLC

The FDA has approved Merck’s Keytruda (pembrolizumab), an anti-PD-1 immunotherapy, the first such therapy to be approved as a first-line treatment for metastatic non-small cell lung cancer.

The agency approved the drug for use with metastatic NSCLC whose tumors have high PD-L1 expression as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. The FDA also expanded the drug’s indication in second-line treatment to include all patients with PD-L1-expressing NSCLC.

An interim analysis showed Keytruda improved both progression-free and overall survival compared to chemotherapy; the trial was halted in June to switch patients on chemotherapy to the Keytruda arm. Similar studies were presented earlier this month at the annual congress of the European Society for Medical Oncology.