FDA Grants Accelerated Approval to Zenbexus for Relapsed or Refractory Multiple Myeloma

The FDA has granted accelerated approval to Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Zenbexus is the first FDA-approved CELMoD (cereblon-modulating protein degrader), marking a new drug class for multiple myeloma. The approval is based on results from the Excaliber-RRMM Phase III trial.