Summary
In August 2026, the FDA granted accelerated approval to Bristol Myers Squibb’s ZENBEXUS (iberdomide), the first-in-class CELMoD, in combination with daratumumab and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy.
Approval rests on the Phase 3 EXCALIBER-RRMM study, where ZDd doubled MRD-negative CR rates vs control: 41% vs 21% (p<0.0001), with MRD negativity regarded as a deep, predictive marker of durable response in myeloma.
BMS is continuing to advance its CELMoD portfolio, with mezigdomide under FDA review in combination with carfilzomib and dexamethasone and golcadomide progressing in lympho...
