Merck announced the FDA accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) 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. 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 (PFS) 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 (PDUFA), or target action, date of January 20, 2024.
“The standard of care for patients with locally advanced cervical cancer has not changed in more than two decades, and the majority of patients will experience recurrence or progression of their disease,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “If approved, KEYTRUDA will be the first immunotherapy available for patients with newly diagnosed high-risk locally advanced cervical cancer. We are committed to working closely with the FDA to bring KEYTRUDA to these patients who are in need of additional treatment options.”
In the U.S., KEYTRUDA has two approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test; and as a single agent, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
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