Prodotti competitors / Area Oncology, Area Kite
FDA grants accelerated approval to Bristol Myers Squibb’s Zenbexus for relapsed multiple myeloma
13 August 2026
Bristol Myers Squibb announced that the U.S. Food and Drug Administration has granted accelerated approval to ZENBEXUS™ (iberdomide), in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
The approval was granted under the FDA accelerated approval pathway and is based on minimal residual disease-negative complete response data from the Phase 3 EXCALIBER-RRMM trial. In the primary efficacy population, the ZDd regimen showed an MRD-negative complete response rate of 41% compared with 21% for daratumumab, bortezomib and dexamethasone.
Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
ZENBEXUS is described as the first FDA-approved CELMoD therapy, belonging to the class of cereblon-modulating protein degraders, for multiple myeloma.
The prescribing information includes boxed warnings for embryo-fetal toxicity and serious venous and arterial thromboembolism, as well as warnings and precautions related to neutropenia, infections and second primary malignancies.
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