Keytruda + Alimta + carboplatin refiled with EMA for metastatic nonsquamous NSCLC.- Merck Inc.
Merck Inc announced that following validation by the European Medicines Agency (EMA), the centralized review process has begun for the company�s Type II Variation, which seeks approval for Keytruda (pembrolizumab) Merck�s anti-PD-1 therapy, in combination with Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).
The application was accepted for review based on overall survival (OS) and progression-free survival (PFS) data from the Phase III KEYNOTE-189 trial, which were recently presented at the American Association of Cancer Research (AACR) 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 NSCLC to be approved in Europe based on overall survival data.
Comment: Merck Inc withdrew its previous European application for Keytruda in combination with pemetrexed and carboplatin as a first-line treatment for metastatic nonsquamous non-small cell lung cancer (NSCLC) in October 2017.
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