FDA Grants Accelerated Approval to Zenbexus (Iberdomide) Combination for Multiple Myeloma

On August 13, 2026, the FDA granted accelerated approval to iberdomide (Zenbexus), the first cereblon E3 ligase modulator (CELMoD), in combination with daratumumab, hyaluronidase-fihj, and dexamethasone, for adults with multiple myeloma who received at least one prior line of therapy. The approval was based on the Phase 3 EXCALIBER-RRMM trial showing a statistically significant improvement in minimal residual disease-negative complete response versus a standard comparator regimen.

• First approval for the CELMoD (cereblon E3 ligase modulator) drug class
• Approved in combination for multiple myeloma patients with prior treatment
• Based on MRD-negative complete response endpoint in Phase 3 EXCALIBER-RRMM trial
• Accelerated approval subject to confirmatory trial verification