FDA Accepts sBLA for Pembrolizumab Monotherapy in First-Line Treatment of Locally Advanced or Metastatic PD-L1–Expressing NSCLC

September 20, 2018 – The U.S. Food and Drug Administration (FDA) granted Priority Review to a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer (NSCLC) in patients whose tumors express programmed cell death ligand 1 (PD-L1, tumor proportion score [TPS] ≥ 1%) without EGFR or ALK … (leggi tutto)