Bristol Myers' (BMY) HCC Combo Drug Accepted for FDA Review

Core Viewpoint - Bristol Myers (BMY) has received FDA acceptance for its supplemental Biologics License Application (sBLA) for the immunotherapy drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC) [1] Company Summary - The sBLA is based on the late-stage CheckMate-9DW study, which demonstrated a statistically significant improvement in overall survival for the Opdivo plus Yervoy combination compared to Lenvima or Nexavar [1] - A final decision from the FDA is expected on April 21, 2025 [1] - Opdivo is already indicated in the U.S. for HCC patients previously treated with Nexavar under accelerated approval [2] - Bristol Myers' shares have decreased by 5.6% year-to-date, while the industry has grown by 1.1% [2] Industry Summary - HCC is the most common type of primary liver cancer, accounting for 75-85% of liver cancers, and is often diagnosed at advanced stages with limited treatment options [2] - The European Medicines Agency (EMA) has validated Bristol Myers' type II variation application for the Opdivo/Yervoy combination as a potential first-line treatment for advanced HCC [5] - Competitors in the HCC market include AstraZeneca, which has an approved combination therapy of Imfinzi (durvalumab) and Imjudo (tremelimumab) for first-line treatment of advanced HCC [6]