FDA grants priority review to sBLA for Keytruda in first line PD-L1 NSCLC.- Merck Inc.

Merck Inc announced that the FDA has accepted for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda (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 PD-L1 (tumor proportion score [TPS] of at least 1%) without EGFR or ALK genomic tumor aberrations. The application is based on data from the pivotal Phase III KEYNOTE-042 trial, one of five Phase III clinical trials with Keytruda in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Jan. 11, 2019.

In addition to KEYNOTE-042, Merck�s leading lung cancer clinical development program includes 10 Phase III trials with Keytruda in combination with other treatments and as monotherapy across histologies and lines of treatment in both advanced and earlier stages of disease.