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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.
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