FDA grants accelerated approval for iberdomide combo in relapsed multiple myeloma, Greek trial participation highlighted
The U.S. FDA has fast-tracked approval of iberdomide with daratumumab and dexamethasone for adult multiple myeloma patients who have received prior therapy, based on data from the EXCALIBER-RRMM study that included Greek sites.
The U.S. Food and Drug Administration has issued an accelerated approval for iberdomide, an oral Cereblon E3 ligase modulator, used together with daratumumab and dexamethasone in adult patients with multiple myeloma who have undergone at least one prior therapy. Approval follows the phase III EXCALIBER-RRMM trial, which reported a 41% MRD-negative complete response rate for the iberdomide regimen compared with 21% for the conventional daratumumab-bortezomib-dex combination.
The international, multicenter study was overseen by a steering committee that includes Professor Thanos Dimopoulos, while the Therapeutic Clinic of the Medical School of the National and Kapodistrian University of Athens, led by Professor Maria Gavriatopoulou, contributed Greek patient data. CELMoD compounds target the cereblon complex to degrade proteins vital for myeloma cell survival and also exert immune-modulating effects. Researchers say the new drug class expands options for relapsed or refractory disease and may improve survival, with further follow-up needed to confirm long-term benefits.
Why it matters
The approval introduces a new drug class for hard-to-treat multiple myeloma and gives Greek patients early access to innovative therapy.
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