Bristol Myers Squibb’s Zenbexus (iberdomide) won U.S. FDA accelerated approval for adults with advanced multiple myeloma that has returned or progressed after at least one prior line of therapy, in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone. The clearance marks the debut of the CELMoDs protein degradation platform approach in myeloma, using a more sensitive remission endpoint. The decision follows Phase 3 results showing higher rates of minimal residual disease (MRD) negativity with the Zenbexus regimen than a Velcade-based comparator. While long-term survival readouts remain pending, the regulator’s action expands an important new treatment option for a large second-line population. Analysts framing the approval as a “franchise-in-the-making” noted that the therapy’s positioning could intensify competition in second-line regimens where generic pressure has weighed on legacy products. BMS also has additional Zenbexus studies planned, including maintenance-style approaches after transplant. Separately, STAT reports the FDA action sets Zenbexus up alongside Johnson & Johnson’s Darzalex in the second-line setting, where physicians currently choose among immunomodulator and proteasome inhibitor-based combinations.