EC Approves Bristol Myers' Opdivo Plus Yervoy for First-Line HCC

Core Insights - The European Commission has approved Bristol Myers' Opdivo plus Yervoy for first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) [1][2] - The approval is based on the phase III CheckMate -9DW study, showing significant improvement in overall survival compared to Lenvima or Nexavar [2] - HCC accounts for 90% of liver cancer cases globally, making it a critical area for treatment advancements [2] Regulatory Approvals - The FDA accepted a supplemental biologics license application for Opdivo plus Yervoy as a first-line treatment for unresectable HCC, with a target action date of April 21, 2025 [3] - The FDA previously granted accelerated approval for the combination as a second-line treatment in 2020 based on phase II CheckMate -040 study results [3] - Additional FDA acceptance for Opdivo plus Yervoy as a potential treatment for microsatellite instability-high or mismatch repair deficient colorectal cancer, with a target action date of June 23, 2025 [7] Financial Performance - Bristol Myers' shares have increased by 18% over the past year, contrasting with a 7% decline in the industry [4] - The company is focusing on new drugs like Opdualag, Reblozyl, and Breyanzi to stabilize revenue amid generic competition for legacy drugs [10] Drug Portfolio Expansion - Opdivo and Yervoy are already approved for multiple oncology indications, including metastatic melanoma and advanced renal cell carcinoma [5] - Opdivo's recent FDA approval for subcutaneous use is expected to enhance its market presence [6] - The approval of Cobenfy for schizophrenia represents a significant addition to the portfolio, with initial sales of $10 million in 2024 [11][12] Challenges Ahead - The outlook for 2025 indicates a potential revenue decline of 18-20% for Bristol Myers' legacy portfolio due to generic competition for key drugs [13]