The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate-9DW trial. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of 21 April 2025.
We have previously reported the submission of an equivalent application by Ono Pharmaceutical and BMS for this combination in Japan.