U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

Approval based on EXCALIBER-RRMM results showing ZDd doubled minimal residual disease-negative complete response rates versus daratumumab, bortezomib and dexamethasone (41% vs. 21%) in relapsed or refractory multiple myeloma(1)

ZENBEXUS marks the arrival of a new treatment class, representing the next chapter in Bristol Myers Squibb’s targeted protein degradation platform

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved ZENBEXUS™ (iberdomide) in combination with daratumumabandhyaluronidase-fihj and dexamethasone (ZDd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.1 Full approval for this indication will be contingent upon verification and description of clinical benefit in the confirmatory trial(s). ZENBEXUS is the first FDA-approved CELMoD, belonging to a new class called cereblon-modulating protein degraders for the treatment of multiple myeloma.1 Please see the Important Safety Information section below, including Boxed WARNINGS for ZENBEXUS regarding embryo-fetal toxicity and venous and arterial thromboembolism. ZENBEXUS is contraindicated in females who are pregnant.1