CHMP recommends Keytruda (pembrolizumab) for the first-line treatment of metastatic NSCLC in adults whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations.- Merck Inc.

Merck announced 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 first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumor mutations.

The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A final decision is expected in the first quarter of 2017. Keytruda is currently approved in Europe for the second-line treatment of patients with locally advanced or metastatic NSCLC 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 targeted therapy before receiving Keytruda. The positive opinion is based on data from KEYNOTE-024, a pivotal study which demonstrated superior overall survival and progression-free survival with Keytruda (pembrolizumab) compared to chemotherapy in patients whose tumors expressed high levels of PD-L1 with no EGFR or ALK positive tumour mutations.