Merck: FDA grants priority review to sBLA for Keytruda+concurrent chemotherapy

Merck announced the U.S. 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 as treatment with definitive intent for newly diagnosed patients with high-risk locally advanced cervical cancer. The sBLA is based on data from the KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, in which KEYTRUDA plus concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to concurrent chemoradiotherapy alone. If approved, this would be Merck’s third approved indication in cervical cancer and first in an earlier stage of the disease. The FDA has set a Prescription Drug User Fee Act, or target action, date of January 20, 2024.