The FDA granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone, for adults with advanced multiple myeloma after at least one prior line of therapy. The decision marks the debut of CELMoDs, a protein-degradation drug class built to route target proteins for elimination via the body’s waste disposal machinery. In the pivotal Phase 3 study behind the approval, Zenbexus won on a more sensitive remission endpoint: 41% of recipients achieved minimal residual disease (MRD)-negative status versus 21% with a Velcade-based regimen. The trial also assesses disease progression delay, with additional outcomes expected in the coming months that could inform a path toward fuller approval. Commercially, the clearance gives Bristol a second-line option positioned alongside Janssen’s Darzalex and established standard regimens using lenalidomide-based backbones. Analysts and coverage focused on how the new MRD benchmark could reshape physician choices in a segment where generics have pressured incumbent franchises. Overall, the approval reinforces the agency’s willingness to use MRD as a decision lever in myeloma, and raises the stakes for competitors developing next-generation oral degraders and combination strategies.
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