Data from Pharmawand - Curated by EPG Health - Date added 12 July 2018

The FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda (pembrolizumab), Merck Inc.’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 II 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.

In addition to KEYNOTE-224, the filing is based on two ongoing pivotal Phase III 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. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Nov. 9, 2018.


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