Bristol Myers Squibb won accelerated approval in the US for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone, to treat adults with advanced multiple myeloma who have received at least one prior line of therapy. The approval also positions iberdomide as the first cleared drug in a new class for myeloma, CELMoDs, built around targeted degradation of cancer-relevant factors through cereblon modulation. In the Phase 3 study underpinning the clearance, Zenbexus-based therapy improved the key endpoint of minimal residual disease (MRD) negativity versus a Velcade (bortezomib) comparator regimen. In a reported interim comparison, 41% of Zenbexus recipients achieved MRD-negative status compared with 21% on Velcade, with overall survival still to be established. Clinically, the FDA clearance extends Zenbexus into the second-line setting alongside established standards including daratumumab combinations. Bristol expects additional results in the coming months, which could determine whether the accelerated approval path can evolve toward full approval.
Get the Daily Brief