The US Food and Drug Administration (FDA) has granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma (MM) who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
MM is a rare blood cancer characterized by the expansion of malignant plasma cells in the bone marrow associated with excessive production of monoclonal immunoglobulins in blood and urine. Individuals with multiple myeloma develop significant osteolytic bone lesions and have immunodeficiency that compromise their longevity and quality of life. The exact underlying cause of disease is currently unknown. Many patients with MM require multiple lines of therapy as patients are prone to the cancer relapsing and/or be refractory to initial therapies.
The approval is largely based on results from the EXCALIBER-RRMM clinical trial (NCT04975997), a two-stage, randomized, multicenter, open-label trial in adults with relapsed or refractory MM who had previously received one or two prior lines of therapy.
A total of 939 patients were randomized to one of three dose levels of iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone (IberDd) or to daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) in stage 1 or to iberdomide 1 mg in combination with daratumumab and hyaluronidase-fihj and dexamethasone (Dd) or DVd in stage 2.
The primary efficacy population included the first 420 patients randomized to iberdomide 1 mg in combination with Dd or the comparator DVd arm across stages 1 and stage 2. The minimal residual disease-negative complete response rate at any time was 41% in the IberDd arm and 21% in the DVd arm.
The prescribing information includes a boxed warning for embryo-fetal toxicity and serious venous and arterial thromboembolism, as well as warnings and precautions for neutropenia, infections, and secondary primary malignancies. Because of the risk of embryo-fetal toxicity, iberdomide is available only through a restricted distribution program called ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS).
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To learn more about MM and other rare cancers, visit https://checkrare.com/diseases/cancers/