iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone - (EXCALIBER RRMM)

February 17, 2026: Bristol Myers Squibb (NYSE: BMY) said the FDA accepted its NDA for iberdomide plus daratumumab and dexamethasone (IberDd) in relapsed/refractory multiple myeloma. The FDA granted Priority Review and Breakthrough Therapy Designation for this indication and set a PDUFA target action date of August 17, 2026. The application is based on a planned analysis of minimal residual disease (MRD) negativity rates from the ongoing Phase 3 EXCALIBER-RRMM trial (NCT04975997); patients continue to be followed for the dual-primary endpoint of progression-free survival (PFS). EXCALIBER-RRMM is a Phase 3, multicenter, two-stage, randomized, open-label study comparing IberDd vs daratumumab/bortezomib/dexamethasone (DVd) in RRMM; secondary endpoints include overall survival, overall response rate, duration of response, time to progression, time to next treatment, and health-related quality of life. The review will proceed under FDA Project Orbis for concurrent review with other countries’ regulators.