Posted by Michael Wonder on 21 Sep 2023
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus concurrent chemoradiotherapy as treatment for patients with newly diagnosed high risk locally advanced cervical cancer
20 September 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A18 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival in these patients.
Merck today announced the US FDA has accepted for priority review a new supplemental biologics license application seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk locally advanced cervical cancer.
