FDA Accepts sBLA for Pembrolizumab Monotherapy in First-Line Treatment of Locally Advanced or Metastatic PD-L1–Expressing NSCLC
The U.S. Food and Drug Administration (FDA) granted Priority Review to a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) 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 genomic tumor aberrations.
The application is based on data from the pivotal phase III KEYNOTE-042 trial, which demonstrated a significant improvement in overall survival. Data from the trial were presented earlier this year by Lopes et al at the 2018 ASCO Annual Meeting (Abstract LBA4).
The FDA has set a Prescription Drug User Fee Act, or target action date, of January 11, 2019.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
