The U.S. Food and Drug Administration granted accelerated approval to Bristol Myers Squibb's Zenbexus (iberdomide) in combination with daratumumab, hyaluronidase-fihj and dexamethasone for adult multiple myeloma patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The decision makes Zenbexus the first FDA-approved CELMoD, a cereblon-modulating protein degrader, and was backed by the Phase 3 EXCALIBER-RRMM trial in relapsed or refractory disease. After a median 16 months of follow-up, 41% of patients on the Zenbexus regimen achieved a minimal residual disease-negative complete response, versus 21% on daratumumab, bortezomib and dexamethasone, marking the first approval in relapsed or refractory multiple myeloma based on MRD-negative complete response. The review ran through Project Orbis, and full approval depends on confirmatory trials verifying clinical benefit. Bristol Myers also has mezigdomide under FDA review with a Prescription Drug User Fee Act target date of May 13, 2027; William Blair said Zenbexus is priced at about $29,500 per 28-day cycle, and Matt Phipps forecast U.S. sales above $1 billion annually in early 2031.