New Drug Application Filed with FDA for Oral Proteasome Inhibitor

Takeda has filed for FDA approval of ixazomib, which could become the first oral proteasome inhibitor for treating multiple myeloma. The New Drug Application (NDA) for ixazomib is based on the results of the phase III TOURMALINE-MM1 trial, which compared ixazomib to placebo—both given in 772 patients with relapsed or refractory myeloma. “If approved, ixazomib, with the convenience of once-a-week oral administration as well as promising efficacy, should provide a very meaningful advance for our patients,” said Dr. Paul Richardson, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center Institute Physician at Dana-Farber Cancer Institute. Click HERE to read the announcement.
Source: International Myeloma Foundation - Category: Hematology Source Type: news