Takeda files NDA at FDA for ixazomib to treat multiple myeloma
Takeda announced that a New Drug Application (NDA) has been submitted to the FDA for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. The NDA submission was based on the pivotal Phase III trial TOURMALINE-MM1, an international, randomized, double-blind, placebo controlled clinical trial of 722 patients designed to evaluate the superiority of ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Patients continue to be treated in this trial and evaluated for long-term outcomes.
Comment: Ixazomib has improved and broader activity and pharmacokinetics compared with bortezomib (Velcade), which is intravenously administered whereas ixazomib is orally administered. Ixazomib also represents a direct threat to carfilzomib (Kyprolis), being a member of the same drug class and also an orally formulated drug.
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