Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for iberdomide in combination with daratumumab and dexamethasone (IberDd) for the treatment of patients with Relapsed or Refractory Multiple Myeloma (RRMM). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2026.

Iberdomide is an investigational oral agent from a novel class of medicines known as cereblon E3 ligase modulators (CELMoD). The filing is supported by data from a planned analysis of Minimal Residual Disease (MRD) negativity rates in the Phase III EXCALIBER-RRMM study. The ongoing trial continues to evaluate (PFS) as a dual primary endpoint alongside MRD negativity.

The FDA has also granted Breakthrough Therapy designation to iberdomide based on these data, underscoring the potential of the therapy to address unmet medical needs in RRMM. The regulatory review is being conducted under the FDA’s Project Orbis initiative, allowing for concurrent review by health authorities in multiple countries.

EXCALIBER-RRMM (NCT04975997) is a multicentre, randomised, open-label Phase III study comparing iberdomide plus daratumumab and dexamethasone (IberDd) against daratumumab, bortezomib and dexamethasone (DVd). The trial enrolled approximately 664 patients in Stage 2, following dose optimisation in Stage 1, which identified 1.0 mg iberdomide as the optimal dose based on safety, pharmacokinetics and efficacy data.

MRD assessment, a highly sensitive method of detecting residual cancer cells beyond conventional diagnostic capabilities, is increasingly being used in multiple myeloma trials as a surrogate endpoint for long-term outcomes such as PFS. Modern detection techniques, including next-generation sequencing and flow cytometry, can identify one malignant cell among up to one million normal cells, providing precise measurement of treatment response.

Bristol Myers Squibb is advancing iberdomide as part of its broader targeted protein degradation (TPD) research platform, which builds on decades of expertise in immunomodulatory drugs and novel protein degrader technologies aimed at addressing previously “undruggable” targets in oncology and beyond.