FDA Grants Priority Review for New KEYTRUDA® (pembrolizumab) Combo Treatment for Third Cervical Cancer Indication

Merck announced the US FDA accepted for priority review its supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA ®, Merck’s anti-PD-1 therapy, in a third cervical cancer indication.  The proposed indication is for KEYTRUDA ® in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer.  The FDA has set a PDUFA date of 20 January 2024.