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AUG 17 2026
UPCOMING · 17 DAYS TO PDUFA

Bristol Myers Squibb iberdomide $BMY

for relapsed or refractory multiple myeloma (combination therapy)

NDA · Priority Review · Breakthrough

Accepted FEB 17 2026.

About

Multiple myeloma is a cancer of plasma cells, a type of white blood cell, which can lead to bone pain, anemia, kidney problems, and frequent infections. Iberdomide is a cereblon E3 ligase modulator, a type of drug that directs the cell's own waste-disposal system to break down specific proteins that cancer cells need to survive. By degrading these key proteins, iberdomide may help stop the growth of myeloma cells in patients who have relapsed or no longer respond to other treatments.

Pivotal trial

EXCALIBER-RRMM Phase 3 active not recruiting NCT04975997

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

Source: ClinicalTrials.gov

Also in development