Opinion Based on Data from KEYNOTE-010, Which Showed Superior Overall Survival Compared to Chemotherapy in Previously-Treated Patients Whose Tumors Express PD-L1
KENILWORTH, N.J., June 27, 2016 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. The CHMP positive opinion for KEYTRUDA will now be reviewed by the European Commission for marketing authorization in the European Union (EU).
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