Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC). This sBLA, which is seeking accelerated approval for this new indication, is based on data from the Phase 2 KEYNOTE-224 trial, which were recently presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The Lancet Oncology. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Nov. 9, 2018.
“There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma, which is the most common type of liver cancer,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “The data supporting our application provide a clear rationale for the advancement of the KEYTRUDA clinical program for hepatocellular carcinoma, and we are grateful for the opportunity to work with the FDA to potentially bring KEYTRUDA to patients living with this difficult-to-treat cancer.”
Merck’s broad immuno-oncology clinical development program includes more than 10 Merck-sponsored studies investigating KEYTRUDA in gastrointestinal cancers, including HCC. In addition to KEYNOTE-224, Merck has two ongoing pivotal Phase 3 studies, KEYNOTE-240 and KEYNOTE-394, evaluating KEYTRUDA as monotherapy in second-line HCC, as well as ongoing trials investigating KEYTRUDA in combination with other treatments including LENVIMA.