Takeda announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for ixazomib for the treatment of patients with relapsed and/or refractory multiple myeloma.
The NDA submission was based on the Phase 3 trial TOURMALINE-MM1. TOURMALINE-MM1 is an international, randomized, double-blind, placebo controlled trial of 722 patients. It was designed to evaluate the superiority of ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adults with relapsed and/or refractory multiple myeloma.
Ixazomib is an investigational oral proteasome inhibitor that disrupts a cancer cells’ ability to survive by blocking the proteasome and disrupting protein metabolism.
For more information call (877) 825-3327 or visit Takeda.com.