Ixazomib Granted Priority Review for Relapsed, Refractory Multiple Myeloma
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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