Bristol Myers : FDA Accepts SBLA For First-Line Treatment Of Unresectable Hepatocellular Carcinoma

(RTTNews) - 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.