FDA grants accelerated approval to iberdomide, the first CELMoD, combined with daratumumab and dexamethasone in multiple myeloma

On 13 August 2026 the FDA granted ACCELERATED approval to iberdomide (Zenbexus), the first cereblon E3 ligase modulator (CELMoD), in COMBINATION with daratumumab and hyaluronidase-fihj and dexamethasone — not as monotherapy — for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. In the randomised, open-label EXCALIBER-RRMM trial (NCT04975997, 939 patients) the regimen achieved MRD-negative complete response in 41% of patients versus 21% with daratumumab, bortezomib and dexamethasone at a median follow-up of 16 months. Accelerated approval rests on this surrogate endpoint and still requires confirmation of clinical benefit. The label carries a boxed warning for embryo-fetal toxicity and for serious venous and arterial thromboembolism, and the drug is distributed only through a restricted programme (REMS).