Posted by Michael Wonder on 23 Apr 2018
EMA validates Type II variation for Merck’s Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy as first-line therapy in metastatic non-squamous NSCLC, based on Phase 3 KEYNOTE-189 trial
23 April 2018 - Merck today announced that following validation by the EMA, the centralised review process has begun for the company’s Type II Variation, which seeks approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer.
The application was accepted for review based on overall survival and progression-free survival data from the Phase 3 KEYNOTE-189 trial, which were recently presented at the American Association of Cancer Research 2018 Annual Meeting and published simultaneously in The New England Journal of Medicine.
If approved by the EMA, this would mark the third indication for Keytruda in metastatic non-small-cell lung cancer to be approved in Europe based on overall survival data.
