FDA approves new blood cancer drug from BMS
A combination drug treatment for patients with rare blood cancer has been approved for use in the US by the FDA.
Produced by Bristol Myers Squibb (BMS), the drug, Zenbexus (iberdomide), is administered orally in combination with J&J’s Darzalex (daratumumab) and dexamethasone for the treatment of multiple myeloma.
Conditions for full approval
Full approval of the drug for treatment of this condition is dependent on whether its clinical benefit can be verified in confirmatory trials, according to BMS.
The drug was previously tested for the treatment of patients with multiple myeloma, an extremely rare cancer that forms in the white blood cells of the bone marrow and will be used for people who have relapsed or not responded to other treatments.
Iberdomide belongs to a new class of drugs known as CELMoDs, which are targeted protein degradation medications able to clear out residual myeloma more quickly and effectively than other treatments.
The FDA have granted accelerated approval for the drug on the condition that it carries a boxed warning, the organisation’s most severe, highlighting the risk of embryo-fetal toxicity. The agency also stipulated that it will only be available through a restricted distribution programme.
Significant results in ongoing trials
A late-stage study’s planned analysis of the drug showed the iberdomide combination significantly reduced minimal residue disease rates in patients with relapsed multiple myeloma compared to those who had undergone standard therapy.
This study will continue to evaluate the longer-term effects of the drug, including progression-free survival rates.
BMS, who say the treatment’s safety profile was generally consistent with previous studies, have announced its list price as $29,500 for a 28-day cycle.
It is expected that around 36,000 people in the US will receive a diagnosis of multiple myeloma this year, according to the American Cancer Society.
The company is also currently testing another treatment for the same disease called mezigdomide, a member of the same CELMoDs family of drugs as iberdomide.
