FDA Grants Accelerated Approval to Bristol Myers Squibb’s ZENBEXUS for Relapsed Multiple Myeloma
Event summary
- FDA granted accelerated approval to Bristol Myers Squibb’s ZENBEXUS (iberdomide) in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for relapsed multiple myeloma patients.
- Approval based on Phase 3 EXCALIBER-RRMM trial showing 41% MRD-negative complete response rate vs. 21% with standard therapy.
- ZENBEXUS is the first FDA-approved CELMoD (cereblon-modulating protein degrader) for multiple myeloma.
- Full approval contingent upon verification of clinical benefit in confirmatory trials.
- Approval marks the first public disclosure of MRD-negative CR data from the EXCALIBER-RRMM trial.
The big picture
This approval solidifies Bristol Myers Squibb’s leadership in targeted protein degradation for multiple myeloma, introducing a new therapeutic class. The focus on MRD-negative complete response as a surrogate endpoint reflects evolving regulatory standards in oncology. With another CELMoD therapy (mezidomide) under review, the company is positioning itself to dominate this emerging treatment paradigm.
What we're watching
- Clinical Validation
- Whether the confirmatory trial will verify progression-free survival benefits to support full approval.
- Market Positioning
- How Bristol Myers Squibb positions ZENBEXUS against existing multiple myeloma treatments in the relapsed setting.
- Pipeline Progress
- The pace at which Bristol Myers Squibb advances its next CELMoD therapy, mezigdomide, currently under FDA review.
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