FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
Regulatory approval: On Aug 13, 2026, the FDA granted accelerated approval to iberdomide (Zenbexus) with subcutaneous daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma after ≥1 prior line including a proteasome inhibitor and an immunomodulatory agent. Approval was supported by EXCALIBER-RRMM, where MRD-negative complete response rates were 41% with IberDd vs 21% with DVd. Labeling includes boxed warnings for embryo-fetal toxicity and serious thromboembolism; access is via ZENBEXUS REMS.
FDA accelerated approval (Aug 13, 2026)
The FDA granted accelerated approval to iberdomide (Zenbexus; Bristol-Myers Squibb) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received ≥1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
Supporting evidence
Efficacy was evaluated in EXCALIBER-RRMM (NCT04975997), a two-stage, randomized, multicenter, open-label trial in adults with relapsed/refractory multiple myeloma who had received 1–2 prior lines. Patients refractory to prior anti-CD38 monoclonal antibody therapy or to prior bortezomib were excluded.
The major efficacy outcome was MRD-negative complete response (CR) at any time. In the primary efficacy population (first 420 patients randomized to iberdomide 1 mg + Dd [n=207] vs DVd [n=213] across stages), the MRD-negative CR rate was 41% (95% CI, 34–48) with IberDd vs 21% (95% CI, 15–27) with DVd (p<0.0001).
Safety and access
Prescribing information includes boxed warnings for embryo-fetal toxicity and serious venous and arterial thromboembolism, and warnings/precautions for neutropenia, infections, and secondary primary malignancies. Because of embryo-fetal risk, iberdomide is available only via ZENBEXUS REMS.
Regulatory notes
The review occurred under Project Orbis with collaboration from Swissmedic, and the application received priority review; iberdomide had breakthrough therapy and orphan drug designations.