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# BMS Files NDA for Multiple Myeloma
- URL: https://www.fdaweb.com/bms-files-nda-for-multiple-myeloma/
- Published: 2026-02-17T12:00:00.000Z
- Updated: 2026-09-14T13:33:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160679

FDA has accepted for priority review a Bristol Myers Squibb NDA for iberdomide in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma. If approved, iberdomide would become the first therapy in a new class of medicines known as cereblon E3 ligase modulators, or CELMoD agents. The oral drug is designed to harness a cell’s protein degradation machinery to target disease-driving proteins in multiple myeloma. The agency has set a user fee review action target date of 8/17.

The submission is based on data from a planned interim analysis of the Phase 3 EXCALIBER-RRMM trial, which is evaluating iberdomide plus daratumumab and dexamethasone (IberDd) against a standard regimen of daratumumab, bortezomib and dexamethasone (DVd) in patients whose disease has relapsed or become refractory to prior therapies.

According to Bristol Myers, the filing is based on rates of minimal residual disease (MRD) negativity, a highly sensitive measure of treatment response that detects small numbers of remaining cancer cells using next-generation sequencing or flow cytometry. MRD negativity has increasingly been used as a surrogate endpoint in myeloma trials and is viewed by regulators as a potential predictor of longer-term outcomes such as progression-free survival.

The EXCALIBER-RRMM study is ongoing, with patients continuing to be followed for progression-free survival, one of the trial’s dual primary endpoints alongside MRD negativity. Secondary endpoints include overall survival, overall response rate, duration of response and health-related quality of life.