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AUG 17 2026
UPCOMING · 75 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 that weakens bones, causes anemia, and can lead to kidney damage and frequent infections. Iberdomide is a targeted therapy that modifies the cell's protein disposal system to mark cancerous plasma cells for destruction. By helping the body eliminate these harmful cells, iberdomide may slow disease progression and reduce symptoms in patients who've stopped responding 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