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ARTICLE | Company News

Takeda submits NDA for ixazomib in MM

July 16, 2015 1:19 AM UTC

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) submitted an NDA to FDA for ixazomib to treat relapsed and/or refractory multiple myeloma. The company based its submission on the ongoing Phase III TOURMALINE-MM1 study. An interim analysis showed ixazomib met the primary endpoint of increasing progression-free survival (see BioCentury Extra, Feb. 10).

Takeda said it expects to submit an MAA to EMA for ixazomib by YE15. The orally available proteasome inhibitor has Orphan Drug designation in the U.S. and EU to treat MM and systemic light-chain amyloidosis, and breakthrough therapy designation from FDA to treat relapsed or refractory systemic light-chain amyloidosis. ...