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Takeda Pharmaceutical Company Limited announced that it has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for ixazomib, the first oral proteasome inhibitor for the treatment of relapsed or refractory multiple myeloma.
The NDA was filed based on the results of TOURMALINE-MM1, a global Phase 3 trial published in the New England Journal of Medicine in April. The trial demonstrated that the all-oral triplet regimen containing ixazomib, lenalidomide and dexamethasone significantly extended the progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma, with a manageable safety profile and the convenience and practicality of oral dosing.
Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies. These malignant plasma cells have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain.
“Multiple myeloma remains a devastating, relapsing and incurable rare cancer. We designed our extensive global Phase 3 clinical trial program, which includes TOURMALINE-MM1, to address the unmet need for an effective, tolerable and conveniently dosed therapy that may reduce some of the burdens that patients currently face,” said Andrew Plump, M.D., Ph.D., Takeda Chief Medical and Scientific Officer. “Should it be approved, the NDA submission of ixazomib will enable the first all-oral, proteasome inhibitor-containing triplet regimen in Japan. We thank the patients and investigators who have contributed to the development of ixazomib and look forward to the opportunity of offering this innovative drug to patients in Japan.”
Ixazomib is a novel oral proteasome inhibitor which is being studied in multiple myeloma and systemic light-chain (AL) amyloidosis. Ixazomib was granted orphan drug designation for the treatment of patients with relapsed or refractory multiple myeloma by the Ministry of Health, Labour and Welfare in February, 2016. Ixazomib became available in the U.S. in December, 2015 under the trade name “NINLARO®”.
