EU CHMP recommends change in marketing authorisation for Keytruda (pembrolizumab) in non-small cell lung cancer- Merck Inc

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Keytruda (pembrolizumab), from Merck Inc. The CHMP adopted a new indication: "Keytruda is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults 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 approved therapy for these mutations prior to receiving Keytruda."

Comment: Keytruda is currently indicated in the U.S. for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda (pembrolizumab).