Bristol-Myers Squibb Wins FDA Approval for Iberdomide, Using Landmark Cancer Endpoint

The FDA approved Bristol-Myers Squibb’s iberdomide combination therapy for adults with relapsed or refractory multiple myeloma.

This regimen combines iberdomide with daratumumab and dexamethasone for patients who have received at least one prior line of therapy. The approval follows results from the Phase III EXCALIBER-RRMM trial.

This marks the first FDA approval in this setting based on Minimal Residual Disease (MRD) negativity data. Using MRD-negativity as a primary endpoint may shorten clinical trials and accelerate patient access to new cancer treatments.

This novel endpoint could reshape trial designs and approval pathways for future hematological malignancy therapies.