Events Details
Bristol Myers Squibb’s Iberdomide NDA Accepted by FDA for Relapsed or Refractory Multiple Myeloma
Wednesday, February 18, 2026
Bristol Myers Squibb has announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for iberdomide in combination with daratumumab and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma.
Iberdomide is an investigational medicine from a new class known as cereblon E3 ligase modulators (CELMoD) agents. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 17 August 2026 for the application. The agency has also granted Breakthrough Therapy designation based on clinical data submitted.
Minimal residual disease refers to the small number of cancer cells that may remain after treatment and cannot be detected using standard diagnostic methods. In multiple myeloma, MRD assessment has become an important tool for measuring depth of response. While MRD negativity does not confirm complete elimination of cancer, it is associated with improved clinical outcomes, including longer remission and survival.
Targeted protein degradation is a research platform developed by Bristol Myers Squibb to eliminate disease-related proteins that were previously considered difficult to target. The company has already commercialised protein degrader medicines for multiple myeloma, including immunomodulatory drugs (IMiDs), which form part of the current standard of care.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 17 August 2026 and has granted Breakthrough Therapy designation for the investigational therapy.
The NDA is supported by results from a planned analysis of minimal residual disease (MRD) negativity rates in the Phase 3 EXCALIBER-RRMM study. The trial is evaluating iberdomide in combination with daratumumab and dexamethasone in patients with RRMM. The study remains ongoing, with progression-free survival (PFS) continuing to be assessed.
The review is being conducted under the FDA’s Project Orbis initiative, which allows for concurrent review by health authorities in several countries.
Source: bms.com
