FDA Clears Iberdomide as First CELMoD for Relapsed Multiple Myeloma
The FDA’s approval of iberdomide introduces a mechanistically distinct oral agent and endorses MRD negativity as a registrational endpoint. Absolute response gains are clinically relevant yet overall survival remains unreported. Confirmation in frontline disease and comparative effectiveness studies will determine its place in evolving myeloma algorithms.
Next steps include label expansion into earlier lines and triplet or quadruplet regimens with BCMA bispecifics. A phase 3 study in newly diagnosed patients is enrolling with MRD as primary endpoint; results expected 2028. Payers will scrutinize cost-effectiveness given daratumumab’s existing dominance and the absence of head-to-head data versus other novel oral agents.
Bristol Myers Squibb: MRD-negative rate exceeds 45% at 24 months in the frontline phase 3 trial by December 2028
Sources (3)
- [1]Primary Source(https://www.statnews.com/2026/08/14/fda-approves-bristol-multiple-myeloma-drug-zenbexus/)
- [2]Supporting Source(https://www.nejm.org/doi/full/10.1056/NEJMoa2301234)
- [3]Supporting Source(https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-iberdomide-zenbexus)