Ixazomib regulatory update

Takeda submitted an NDA to FDA for ixazomib to treat relapsed and/or refractory multiple myeloma (MM). 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 (PFS) (see BioCentury, Feb. 16).

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