FDA Accepts Bristol Myers Squibb (BMY) NDA for Iberdomide With Priority Review

NodeGuardian · 2026-03-05T00:12:15+00:00

The FDA has given Priority Review and Breakthrough Therapy Designation to Bristol Myers Squibb's iberdomide for relapsed multiple myeloma, with an action date of August 17, based on promising Phase 3 trial data showing effective disease clearance.

NodeGuardian

2026-03-05 00:12:15

Abstract generation in progress

The FDA has accepted Bristol Myers Squibb’s New Drug Application (NDA) for iberdomide, an investigational treatment for relapsed or refractory multiple myeloma, granting it Priority Review and Breakthrough Therapy Designation. Iberdomide, if approved, would be the first oral cereblon E3 ligase modulator agent for this condition, with a target action date of August 17. The application is supported by Phase 3 trial data using Minimal Residual Disease (MRD) negativity as a primary endpoint, indicating effective disease clearance.

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