Merck’s application for KEYTRUDA® combined with chemoradiotherapy for high-risk locally advanced cervical cancer has been granted priority review by the FDA. This follows the successful results from the Phase 3 KEYNOTE-A18 trial, demonstrating a significant improvement in progression-free survival. If approved, it would be Merck’s third indication for cervical cancer and the first for an earlier stage of the disease. The FDA aims to decide by January 20, 2024.
Merck’s Dr. Gursel Aktan emphasized the need for additional treatment options in cervical cancer, which has seen limited advancements for over two decades. KEYTRUDA could become the first immunotherapy option for newly diagnosed high-risk locally advanced cervical cancer patients.
KEYTRUDA has two existing approved indications in cervical cancer, either in combination with chemotherapy or as a single agent, for patients with recurrent or metastatic cervical cancer expressing PD-L1.
The KEYNOTE-A18 trial evaluated KEYTRUDA in combination with chemoradiotherapy for newly diagnosed high-risk locally advanced cervical cancer, achieving a statistically significant and clinically meaningful improvement in progression-free survival compared to chemoradiotherapy alone.
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