FDA grants accelerated approval to Bristol Myers Squibb's oral multiple myeloma treatment
The US Food and Drug Administration has granted accelerated approval to Bristol Myers Squibb's (BMY) oral combination treatment for patients with a rare form of blood cancer whose illness had relapsed or failed to respond to existing therapies.
The drug, iberdomide — sold under the brand name Zenbexus — is administered in combination with Johnson & Johnson's (JNJ) Darzalex and dexamethasone, a prescription anti-inflammatory medication. Full approval will be contingent on verification of clinical benefit in confirmatory trials.
Iberdomide belongs to a new class of drugs called CELMoDs, which target the cereblon protein, enabling the body to clear out myeloma cells more quickly and effectively than older treatments. It was evaluated in patients with relapsed or refractory multiple myeloma, a cancer of plasma cells that accumulates in the bone marrow.
The accelerated approval carries a boxed warning — the most severe designation issued by the FDA — flagging the risk of embryo-fetal toxicity. The agency said the drug will be available only through a restricted distribution program.
Bristol Myers Squibb has set the list price of Zenbexus at $29,500 per 28-day cycle and expects the product to be available within the coming weeks.
The approval is based on data from a planned analysis of a late-stage study showing that the iberdomide combination significantly improved minimal residual disease rates compared with standard therapy. Minimal residual disease refers to the small number of cancer cells that may remain undetectable in a patient's body after treatment using conventional diagnostic methods. The late-stage trial remains ongoing to assess progression-free survival.
Approximately 36,000 new cases of multiple myeloma are expected to be diagnosed in the US this year, according to the American Cancer Society. Bristol Myers Squibb is also evaluating mezigdomide, a separate myeloma drug from the same CELMoD class as iberdomide, in clinical trials.