Bristol Myers Squibb won an FDA accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone, for adult patients with advanced multiple myeloma. The clearance adds Zenbexus to second-line treatment regimens and marks the debut of the CELMoDs class in the U.S. BMS’s prior Celgene-acquired asset now enters a crowded myeloma market amid intensifying competition from established CD38- and immunomodulatory-based combinations. In the supporting Phase 3 data, the Zenbexus arm showed higher minimal residual disease (MRD) negativity rates than a Velcade-based comparator regimen. Analysts highlighted the commercial importance of the MRD-positive differentiation, including potential regimen displacement in second line as oncologists choose therapies that push MRD deeper earlier. BMS also indicated follow-on studies, including maintenance approaches, are expected to generate additional readouts. The approval immediately affects clinical decision-making for second-line multiple myeloma and sets up new comparisons for combination sequencing as more data mature across BMS’s CELMoDs pipeline.
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