NDA for Ixazomib to Treat Myeloma Submitted to FDA

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Takeda has submitted a NDA to the FDA for ixazomib for the treatment of relapsed and/or refractory multiple myeloma.
Takeda has submitted a NDA to the FDA for ixazomib for the treatment of relapsed and/or refractory multiple myeloma.

Takeda Oncology announced this week that the company has submitted a New Drug Application (NDA) to the U.S. 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 international, double-blind, placebo-controlled, phase 3 TOURMALINE-MM1 trial, which evaluated the superiority of ixazomib plus lenalidomide and dexamethasone versus placebo lenalidomide and dexamethasone. The trial included 722 adult patients with relapsed and/or refractory multiple myeloma.

“The TOURMALINE-MM1 study is the first in a series of five phase 3 trials within our ixazomib program, which is designed to evaluate whether sustained therapy with a proteasome inhibitor, delivered orally, improves the clinical outcomes of patients living with multiple myeloma or with systemic light-chain (AL) amyloidosis,” said Andrew Plump, MD, PhD, Takeda's Chief Medical and Scientific Officer.

RELATED: Ixazomib Improves Progression-Free Survival in Relapsed, Refractory Multiple Myeloma

“This submission marks an important step in Takeda's ongoing commitment to innovation for patients living with multiple myeloma. We thank the patients and their families for placing their trust in us and in ixazomib as they continue to participate in the TOURMALINE program.”

Ixazomib is an investigational oral proteasome inhibitor that is being studied alone and in combination with lenalidomide and dexamethasone for the treatment of AL amyloidosis, multiple myeloma, and other cancers.

Reference

  1. Takeda submits new drug application for ixazomib for patients with relapsed/refractory multiple myeloma [news release]. Cambridge, MA: Takeda Pharmaceutical Company Limited; July 14, 2015. http://investor.millennium.com/phoenix.zhtml?c=80159&p=irol-newsArticle&ID=2067656. Accessed July 16, 2015.

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