The FDA has granted accelerated approval to Bristol Myers Squibb’s Zenbexus, the first FDA-approved cereblon E3 ligase modulator, or CELMoD, a new class of treatment for multiple myeloma.
Zenbexus (iberdomide), in combination with daratumumab and hyaluronidase-fihj and dexamethasone, was approved for adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
The approval was based on the phase 3 Excaliber-Rrmm trial. After a median follow-up of 16 months, 41% of patients receiving the Zenbexus combination had no detectable signs of cancer remaining after treatment, compared with 21% of patients receiving daratumumab, bortezomib and dexamethasone.
Fatal adverse reactions occurred in 10 patients, or 4.9%, who received Zenbexus. The combination can cause serious, life-threatening or fatal infections and severe neutropenia. Zenbexus also carries boxed warnings for embryo-fetal toxicity and venous and arterial thromboembolism. Full approval for the indication is contingent on verification of clinical benefit in a confirmatory trial.
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