martedì, 16 aprile 2024
4 Maggio 2018

FDA Grants Priority Review for Full Approval of Frontline Pembrolizumab Combo in NSCLC

April 30, 2018 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor. The sBLA is based on the phase III KEYNOTE-189 trial, in which adding pembrolizumab to pemetrexed and either cisplatin or carboplatin in … (leggi tutto)