The FDA has granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) for adult patients with advanced multiple myeloma that has returned or is refractory to treatment, clearing a first-of-its-kind (for BMS) successor therapy in the CELMoDs class. Zenbexus is indicated in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone, in the second-line setting after at least one prior therapy. The approval follows Phase 3 evidence supporting improved depth of response, with the regimen raising the proportion of patients achieving minimal residual disease (MRD) negativity compared with a bortezomib (Velcade)-based control. The company expects additional results that could support conversion to full approval as well as continued development in other disease phases. Zenbexus also reinforces BMS’s push to sustain its myeloma franchise as generic competition pressures older backbones. The accelerated clearance could drive prescriber adoption if ongoing studies confirm whether MRD improvements translate into longer progression-free or overall survival.
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