The Investor
17 Feb 2026, 23:08
Bristol Myers Squibb announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for iberdomide in combination with daratumumab and dexamethasone (IberDd) for patients with relapsed or refractory multiple myeloma (RRMM).
The FDA granted Breakthrough Therapy Designation and Priority Review, assigning a PDUFA target action date of August 17, 2026. Iberdomide is an investigational cereblon E3 ligase modulator (CELMoD) agent and could become the first approved therapy in this novel class.
The NDA is based on data from the Phase 3 EXCALIBER-RRMM trial, which demonstrated favorable minimal residual disease (MRD) negativity rates in a planned analysis. The ongoing study is also evaluating progression-free survival (PFS), with dual primary endpoints of MRD negativity and PFS. Approximately 664 patients were randomized in Stage 2 to receive either IberDd or a comparator regimen of daratumumab, bortezomib and dexamethasone.
The FDA is reviewing the application under Project Orbis, enabling concurrent evaluation by regulatory authorities in multiple countries.
If approved, iberdomide would expand Bristol Myers Squibb’s targeted protein degradation portfolio and build on its established presence in multiple myeloma, where IMiD-based therapies have become standard of care.
Business Wire
The FDA granted Breakthrough Therapy Designation and Priority Review, assigning a PDUFA target action date of August 17, 2026. Iberdomide is an investigational cereblon E3 ligase modulator (CELMoD) agent and could become the first approved therapy in this novel class.
The NDA is based on data from the Phase 3 EXCALIBER-RRMM trial, which demonstrated favorable minimal residual disease (MRD) negativity rates in a planned analysis. The ongoing study is also evaluating progression-free survival (PFS), with dual primary endpoints of MRD negativity and PFS. Approximately 664 patients were randomized in Stage 2 to receive either IberDd or a comparator regimen of daratumumab, bortezomib and dexamethasone.
The FDA is reviewing the application under Project Orbis, enabling concurrent evaluation by regulatory authorities in multiple countries.
If approved, iberdomide would expand Bristol Myers Squibb’s targeted protein degradation portfolio and build on its established presence in multiple myeloma, where IMiD-based therapies have become standard of care.
Business Wire