FDA Approves Bristol's Zenbexus for Advanced Myeloma
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- FDA approved Zenbexus, Bristol Myers Squibb's oral treatment for advanced multiple myeloma, marking the debut of CELMoDs — a new class of blood cancer drugs that redirect a cell's natural machinery to eliminate cancer-causing proteins.
- Zenbexus is the first drug cleared by U.S. regulators using a more sensitive measure of remission, according to STAT.
- A U.S. appeals court ruled 3-0 that a lower-court judge erred in dismissing a $6.7 billion lawsuit accusing Bristol Myers Squibb of cheating former Celgene shareholders by delaying federal approval for three drugs.
- UMB Bank was found entitled to represent Celgene shareholders as a trustee despite an error in how it was appointed, reviving the case.
- The lawsuit stems from Bristol Myers' $80.3 billion 2019 acquisition of Celgene; shareholders holding 'contingent value rights' were entitled to an extra $9 per share if Bristol won timely U.S. regulatory approvals for three Celgene drugs.
Why it matters: Zenbexus's approval opens a new treatment pathway for advanced multiple myeloma patients using a more sensitive remission benchmark, while the revived $6.7 billion lawsuit — tied to Bristol's $80.3 billion Celgene acquisition and contingent value rights worth $9 per share — puts billions in potential liability back on the table over delayed drug approvals central to the deal's value.
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