First CELMoD Drug Zenbexus Wins FDA Accelerated Approval for Multiple Myeloma

　　【Approval Highlights】

　　Bristol Myers Squibb announced that the U.S.Food and Drug Administration(FDA)has approved Zenbexus(iberdomide)in combination with daratumumab and hyaluronidase-fihj plus dexamethasone(the ZDd regimen)for adult patients with multiple myeloma who have received at least one prior line of therapy,including a proteasome inhibitor and an immunomodulatory agent.This indication is granted under accelerated approval,with continued approval contingent on verification and description of clinical benefit in confirmatory trials.

　　【A New Therapeutic Class】

　　Zenbexus is the first CELMoD drug approved by the FDA,belonging to a new class of agents known as cereblon modulating protein degraders.Important safety information includes boxed warnings for embryo-fetal toxicity and for venous and arterial thromboembolism.Zenbexus is contraindicated in pregnant women.

　　【Key Study Data】

　　The approval was based on results from the EXCALIBER-RRMM study,which showed that in relapsed or refractory multiple myeloma,the ZDd regimen doubled the rate of minimal residual disease(MRD)-negative complete response compared with daratumumab,bortezomib,and dexamethasone.

　　【Stakeholder Perspectives】

　　Cristian Massacesi,M.D.,Chief Medical Officer and Head of Development at Bristol Myers Squibb,said that as the first approved CELMoD drug,Zenbexus marks the arrival of a new therapeutic class and validates the company's targeted protein degradation platform—particularly its CELMoD program—adding that he believes this is only the beginning.Sagar Lonial,M.D.,FACP,FASCO,lead investigator of EXCALIBER-RRMM and Chief Medical Officer of Emory University's Winship Cancer Institute,noted the approval brings a long-awaited new treatment class with the potential to meaningfully change outcomes.Heather Cooper Ortner,President and CEO of the International Myeloma Foundation,emphasized that for patients facing first relapse,every new option gives care teams additional choices and brings renewed hope.

　　【Review Pathway and Pipeline】

　　Zenbexus received Breakthrough Therapy designation and accelerated approval based on MRD-negative complete response at any time point in the EXCALIBER-RRMM study,and was reviewed under the FDA's Project Orbis initiative,which allows simultaneous review by multiple international regulators.Notably,another investigational CELMoD agent,mezigdomide,in combination with carfilzomib and dexamethasone,is currently under FDA review,with a Prescription Drug User Fee Act(PDUFA)target date of May 13,2027.Bristol Myers Squibb also continues to offer patient support programs and resources to help eligible patients access therapies including Zenbexus.