Merck’s KEYTRUDA (pembrolizumab) Approved by the European Commission for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1

Merck’s KEYTRUDA^® (pembrolizumab) Approved by the European Commission for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1

Approval Based on Trial Results Demonstrating Superior Overall Survival Compared to Chemotherapy in Previously-Treated Patients

KENILWORTH, N.J., Aug. 2, 2016 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA^®(pembrolizumab), the company’s anti-PD-1 therapy, at a dose of 2 mg/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. The EC approval allows marketing of KEYTRUDA in all 28 EU member states.

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Republicado por:RM Consult