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Takeda Submits a New Drug Application for Novel, Oral Proteasome Inhibitor Ixazomib in Japan

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Additional Relevant Details 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.
http://www.takeda.co...
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Catalyst Date
Occurred on:
Jul 04, 2016
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Related Keywords Ixazomib, Lenalidomide, Dexamethasone, Tourmaline-mm1, Refractory Multiple Myeloma