FDA Grants Priority Review to Pembrolizumab as First-Line Treatment in NSCLC Subset
Posted: Friday, September 21, 2018
The U.S. Food and Drug Administration (FDA) recently granted Priority Review to the new supplemental biologics license application seeking approval of the anti–PD-1 therapy pembrolizumab (Keytruda) as monotherapy in the first-line treatment of locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.
The application is based on data from the ongoing phase III KEYNOTE-042 trial (ClinicalTrials.gov identifier NCT02220894), one of five clinical trials assessing pembrolizumab in NSCLC. Data from the trial were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA4) and previously covered by JNCCN 360.
The FDA has set a Prescription Drug User Fee Act, or target action date, of January 11, 2019.
