Posted by Michael Wonder on 13 Sep 2018
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients whose tumours express PD-L1 (TPS ≥1%)
12 September 2018 - Application Based on Overall Survival Data from Pivotal Phase 3 KEYNOTE-042 Trial.
Merck today announced that the U.S. FDA has accepted for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic non-squamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumours express PD-L1 (tumour proportion score [TPS] ≥1%) without EGFR or ALK genomic tumour aberrations. The application is based on data from the pivotal Phase 3 KEYNOTE-042 trial, one of five Phase 3 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 Annual Meeting.
The FDA has set a Prescription Drug User Fee Act, or target action, date of 11 January 2019.
