Merck Reports the US FDA Acceptance of sBLA and Granted Priority Review for Keytruda to Treat Newly Diagnosed High-Risk Locally Advanced Cervical Cancer Shots: The US FDA has accepted sBLA
Shots:
- The US FDA has accepted sBLA and granted priority review seeking approval for Keytruda + external beam radiotherapy (EBRT) and concurrent CT, followed by brachytherapy as treatment with definitive intent for newly diagnosed patients with high-risk locally advanced cervical cancer. The US FDA’s decision is expected in Jan 2024
- The sBLA was based on the P-III trial (KEYNOTE-A18/ENGOT-cx11/GOG-3047) evaluating Keytruda + EBRT & concurrent CT vs PBO + concurrent CT in 1060 patients. The trial was sponsored by Merck and conducted in collaboration with ENGOT groups and the GOG Foundation, Inc.
- The results showed a significant clinical improvement in PFS over concurrent chemoradiotherapy alone
Ref: Businesswire | Image: Merck
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