Posted by Michael Wonder on 03 Aug 2016
Merck’s Keytruda (pembrolizumab) approved by the European Commission for patients with advanced non-small cell lung cancer whose tumors express PD-L1
3 August 2016 - Approval based on trial results demonstrating superior overall survival compared to chemotherapy in previously-treated patients.
Merck today announced that the 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 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.
The approval is based on findings from KEYNOTE-010, a pivotal study which showed Keytruda significantly improved overall survival compared to standard of care chemotherapy.
