FDA Grants Accelerated Approval for New Multiple Myeloma Treatment Zenbexus

The FDA has granted accelerated approval to Zenbexus (iberdomide) in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for adults with relapsed or refractory multiple myeloma after at least one prior therapy. This decision, based on the EXCALIBER-RRMM trial, showed the Zenbexus regimen doubled the minimal residual disease-negative complete response rate. The approval includes boxed warnings for embryo-fetal toxicity and thromboembolism, with full approval contingent on confirmatory trials.