Bristol Myers Squibb won an FDA accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-dexamethasone for advanced multiple myeloma, marking the debut of a new “CELMoD” protein-degradation class in the indication. The agency cleared the regimen based on Phase 3 data showing superiority for achieving minimal residual disease (MRD) negativity versus a comparator velcade-based regimen. For recipients, 41% achieved MRD-negative status compared with 21% on the velcade arm, according to the Phase 3 readout cited in the coverage. The trial also measures disease progression endpoints, with BMS planning additional results in the following months that could support a path toward full approval. The approval expands second-line treatment options in the US and underscores how MRD-sensitive remission measures are increasingly shaping myeloma regulatory decisions.
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