Research & Development
US FDA grants Merck's Keytruda priority review for new supplemental biologics license application
13 July 2018 -

The US Food and Drug Administration (FDA) has accepted and offered priority review for a new supplemental biologics license application for United States-based Merck's Keytruda intended for the treatment for earlier treated patients with advanced hepatocellular carcinoma, it was reported yesterday.

The new supplemental biologics license application is based on data from the Phase two KEYNOTE-224 trial, which were recently presented at the 2018 American Society of Clinical Oncology Annual Meeting and published simultaneously in The Lancet Oncology.

The company's broad immuno-oncology clinical development program includes more than 10 Merck-sponsored studies investigating the product in gastrointestinal cancers, including hepatocellular carcinoma. In addition to KEYNOTE-224, the company has two ongoing pivotal Phase three studies, KEYNOTE-240 and KEYNOTE-394, assessing the product as monotherapy in second-line hepatocellular carcinoma, as well as ongoing trials investigating KEYTRUDA in combination with other treatments including LENVIMA.