Phase 3 Study of Takeda’s Ixazomib Enrolls First Patient

Takeda said last week that the first patient has enrolled in its global Phase 3 study of ixazomib as a maintenance therapy in newly diagnosed multiple myeloma patients.

The Tourmaline-MM-4 study will evaluate the oral proteasome inhibitor ixazomib (MLN9708) in patients who have responded to initial therapy and have not undergone an autologous stem cell transplant. The study complements an actively enrolling Phase 3 maintenance study in patients who do receive ASCT.

Ixazomib, which was granted orphan drug designation for multiple myeloma in both the U.S. and Europe in 2011, is the first oral proteasome inhibitor to enter Phase 3 clinical trials.

Takeda expects to submit an NDA to the FDA during the current fiscal year, which ends March 31, 2016, company spokesman Shawn Goodman said. — Jonathon Shacat