FDA approves iberdomide for multiple myeloma

MRD-negative complete response occurred in 41% of patients receiving ZDd vs 21% with DVd in the phase 3 EXCALIBER-RRMM trial.

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The FDA granted accelerated approval to iberdomide for adults with multiple myeloma who had prior therapy including a proteasome inhibitor and an immunomodulatory agent.
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Iberdomide is the first cereblon E3 ligase modulator approved by the FDA and is part of the cereblon-modulating protein degrader class.
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The approval was based on the phase 3 EXCALIBER-RRMM trial, which compared iberdomide with daratumumab and dexamethasone to a standard regimen.
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At 16 months, 41% of patients receiving the iberdomide regimen achieved MRD-negative complete response compared to 21% in the control group.
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Iberdomide has serious adverse reactions, including pneumonia and infections, and carries boxed warnings for embryo-fetal toxicity and thromboembolism.

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