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MAY 13 2027
UPCOMING · 226 DAYS TO PDUFA

Bristol Myers Squibb — mezigdomide $BMY

for relapsed or refractory multiple myeloma (in combination with carfilzomib and dexamethasone)

NDA · Standard Review

Accepted JUL 13 2026.

About

Multiple myeloma is a cancer of plasma cells, the white blood cells that normally make antibodies, and it often causes no symptoms at first before progressing to bone pain, anemia, kidney problems, and infections. Mezigdomide is an oral drug that binds to a protein called cereblon, part of the cell's built-in disposal system, and redirects it to break down specific proteins that myeloma cells rely on to grow. Because those proteins help drive the cancer, tagging them for destruction may slow or stop the disease in people whose myeloma has returned or stopped responding to earlier treatment.

Pivotal trial

SUCCESSOR-2 Phase 3 active not recruiting NCT05552976

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.

Source: ClinicalTrials.gov

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