FDA Grants Priority Review to Merck’s Application for KEYTRUDA (pembrolizumab) as Part of Treatment for Early-Stage Cervical Cancer

On September 20, Merck announced that the U.S. Food and Drug Administration (FDA) granted priority review status to Merck’s supplemental Biologics License Application (sBLA) seeking approval for its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy, as a treatment for newly diagnosed high-risk locally advanced cervical cancer.  According to the press release, the application is supported by positive findings from a Phase 3 KEYNOTE-A18 trial, which demonstrated a significant improvement in progression-free survival in patients receiving KEYTRUDA with the concurrent chemoradiotherapy, when compared to patients receiving the concurrent chemoradiotherapy alone. FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 20, 2024, for the application.