FDA Approval Sought for Frontline Pembrolizumab Combo in Squamous NSCLC

May 3, 2018 – A supplemental biologics license application (sBLA) has been submitted to the FDA for the use of pembrolizumab in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer (sNSCLC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor. The sBLA is based on findings from the phase III KEYNOTE-407 trial (NCT02775435), which evenly randomized 560 treatment-naive patients with … (leggi tutto)