BMS has secured the first FDA approval for a CELMoD therapy with the clearance of Zenbexus (iberdomide) as part of a combination for previously treated multiple myeloma.
Zenbexus is specifically approved in combination with Johnson & Johnson's Darzalex and dexamethasone to treat adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
The FDA approval is an accelerated approval based on minimal residual disease (MRD)-negative complete response data from the phase 3 Excaliber-RRMM trial, where the Zenbexus-based regimen drove a 41% MRD-negative complete response versus 21% for the standard Darzalex, Velcade, and dexamethasone regimen.
The approval marks the first U.S. nod for a new multiple myeloma drug grounded directly in MRD status and for a CELMoD as a new class of protein degraders.
Zenbexus carries a boxed warning for embryo-fetal toxicity and serious venous and arterial thromboembolism and is available only through a restricted distribution program.
Sources:
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