The European Medicines Agency's Committee for Medicinal Products for Human Use recommended Merck & Co. Inc.'s Keytruda for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumors have high PD-L1 expression.
The CHMP's positive opinion is based on Keytruda's superior performance in a phase 3 trial, compared to chemotherapy.
The European Commission will now review the recommendation for the drug's marketing authorization in the EU, with a decision expected in the first quarter of 2017.
Keytruda is currently approved in Europe as a second-line treatment of patients with metastatic NSCLC who have received one prior chemotherapy regimen.