Merck’s Keytruda Approved for Expanded Label Through New Pilot Program

The FDA approved an expanded label for Merck’s chemotherapy combination treatment Keytruda (pembrolizumab) as a first-line treatment for patients with metastatic, non-squamous non-small cell lung cancer who have no EGFR or ALK genomic tumor aberrations.

The agency approved the drug in combination with Alimta (pemetrexed) and platinum chemotherapy, based on a pivotal Phase 3 trial that showed the treatment reduces the risk of death by half when compared to chemotherapy alone.

Keytruda’s approval marks the second achieved through the agency’s real time oncology review pilot program, which allows the agency to analyze data before an application is submitted.