FDA Grants Frontline Pembrolizumab Regimen Priority Review for Squamous NSCLC

July 2, 2018 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for first-line pembrolizumab for use in combination with carboplatin/paclitaxel or nab-paclitaxel for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC), regardless of PD-L1 expression. The sBLA is based on results from the phase III KEYNOTE-407 trial, in which combining pembrolizumab with chemotherapy reduced … (leggi tutto)