New indication approved in Europe for Merck's Keytruda

The European Commission has approved US pharma giant Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, at a dose of 2mg/kg every three weeks, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.

Patients with EGFR or ALK positive tumor mutations should also have received approved therapy for these mutations prior to receiving Keytruda. It allows marketing of the drug in all 28 EU member states.

The approval is based on findings from KEYNOTE-010, a pivotal study which showed KEYTRUDA significantly improved overall survival (OS) compared to standard of care chemotherapy.