Posted by Michael Wonder on 17 Dec 2016
European Medicines Agency’s CHMP recommends Merck’s Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumours have high PD-L1 expression with no EGFR or ALK positive tumour mutations
16 December 2016 - First anti-PD-1 therapy to receive a CHMP positive opinion for previously untreated patients with metastatic non-small-cell lung cancer.
Merck announced today that the CHMP of the 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 tumours have high PD-L1 expression (tumour proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumour mutations.
The recommendation will now be reviewed by the European Commission for marketing authorisation 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 tumours express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving Keytruda.
