The FDA granted accelerated approval to Bristol Myers Squibb’s iberdomide (Zenbexus), an oral CELMoD regimen for adults with relapsed or refractory multiple myeloma after at least one prior line of therapy. The clearance marks the debut of this novel drug class in myeloma in the U.S. and is tied to a more sensitive remission endpoint than regulators have traditionally used in the disease space. The approval is based on Phase 3 data showing Zenbexus plus daratumumab (Darzalex) and dexamethasone improved the rate of minimal residual disease (MRD)-negative status versus a bortezomib (Velcade)-based comparator. BMS reported 41% of recipients achieving MRD-negative status versus 21% on Velcade. Full survival data are still pending. BMS positioned Zenbexus for second-line use alongside Darzalex and dexamethasone, with investors and analysts expecting the regimen to reshape treatment sequencing and combination selection. The company also has a “maintenance” study underway in patients post–bone marrow transplant, which could broaden uptake if it demonstrates durable control. Separately, BMS is expected to report additional data in coming months that may support conversion from accelerated to full approval.