Bristol Myers Squibb (BMY) announced that the U.S. Food and Drug Administration has accepted the supplemental Biologics License Application or sBLA for Opdivo (nivolumab) plus Yervoy (ipilimumab) as potential first-line treatment for adult patients with unresectable hepatocellular carcinoma or HCC.
The acceptance is based on Phase 3 CheckMate -9DW trial results demonstrating improved survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator's choice of lenvatinib or sorafenib in this patient population.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 21, 2025.
Hepatocellular carcinoma is the most common form of liver cancer and is often diagnosed when surgery is no longer an option.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.