Posted by Michael Wonder on 27 Nov 2019
Merck’s Keytruda (pembrolizumab) now approved in China for first-line treatment of metastatic squamous non-small cell lung cancer in combination with chemotherapy
26 November 2019 - Third approval for Keytruda in first-line NSCLC in China in less than one year.
Merck today announced that Keytruda, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). This new indication was granted full approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-407 trial, including interim data from an extension of the global study in Chinese patients. With this third first-line approval in NSCLC in less than one year, Keytruda is now the first anti-PD-1 therapy approved in China in combination with chemotherapy for the first-line treatment of squamous and non-squamous NSCLC, as well as in the monotherapy setting for appropriate patients with NSCLC (tumoor proportion score [TPS] ≥1%).
