ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) - (EXCALIBER-RRMM)

August 11, 2026: Bristol Myers Squibb (NYSE: BMY) said the FDA granted accelerated approval to ZENBEXUS (iberdomide) plus daratumumab/hyaluronidase-fihj and dexamethasone (ZDd) for adults with multiple myeloma after at least one prior line including a proteasome inhibitor and an immunomodulatory agent. The company said this is the first FDA-approved CELMoD and the first relapsed/refractory multiple myeloma approval based on MRD-negative complete response.

Approval was based on the Phase 3 EXCALIBER-RRMM trial comparing ZDd (n=207) vs daratumumab, bortezomib and dexamethasone (DVd; n=213). At median 16-month follow-up, MRD-negative CR, a dual primary endpoint, was 41% with ZDd versus 21% with DVd (p<0.0001; 95% CI 34-48 vs 15-27). The study remains ongoing for the other dual primary endpoint, progression-free survival; full approval is contingent on confirmatory clinical benefit, and full EXCALIBER-RRMM data are expected this year.

Safety: 7.8% discontinued ZDd due to adverse reactions; neutropenia occurred in 90.2%, infections in 78.9%, serious adverse reactions in 58.3%, and fatal adverse reactions in 4.9%. An additional catalyst disclosed: mezigdomide plus carfilzomib/dexamethasone is under FDA review with a PDUFA date of May 13, 2027.