Takeda files for US approval of ixazomib in multiple myeloma

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has submitted a New Drug Application to the US Food and Drug Administration 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.

First regulatory filing for ixazomib