Takeda announced that the Food and Drug Administration (FDA) has granted Priority Review status to the New Drug Application (NDA) for ixazomib for the treatment of patients with relapsed and/or refractory multiple myeloma.
The NDA submission was primarily based on the results of the pivotal Phase 3 trial, TOURMALINE-MM1, an international, randomized, double-blind, placebo controlled clinical trial 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. TOURMALINE-MM1 study is ongoing, along with other four global ixazomib Phase 3 trials for multiple myeloma and systemic light-chain (AL) amyloidosis.
Ixazomib is the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.
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