BRIEF—Third approval for Keytruda in first-line NSCLC in China in less than a year

US pharma giant Merck & Co’s mega-blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) 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 III 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 (tumor proportion score [TPS] ≥1%), according to Merck.