FDA Grants Priority Review to Ixazomib for Patients With Relapsed/Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Priority Review status to the New Drug Application for the investigational oral proteasome inhibitor ixazomib for the treatment of patients with relapsed or refractory multiple myeloma, Takeda Pharmaceuticals announced.
The New Drug Application submission for ixazomib was based on the results of the first prespecified interim analysis of the pivotal phase III TOURMALINE-MM1 trial. This study is an international, randomized, double-blind, placebo-controlled clinical trial of 722 patients designed to evaluate the superiority of ixazomib plus lenalidomide (Revlimid) and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Patients continue to be treated to progression in this trial and will be evaluated for long-term outcomes.
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