U.S. FDA has approved Takeda’s Ninlaro®(ixazomib) capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ninlaro is a once-weekly pill. Ninlaro was developed in the Cambridge lab of the Takeda’s cancer division, formerly known as Millennium Pharmaceuticals Inc. It is Takeda’s first new multiple myeloma medicine in the U.S. since Velcade, which won approval in 2003 and, unlike Ninlaro, is taken by injection at clinics. Takeda is testing Ninlaro on patients in a late-stage clinical trial as a first-line treatment, meaning it can be given to newly diagnosed patients.
There are about 26,850 new cases of multiple myeloma in the United States each year and about 11,240 deaths, according to National Cancer Institute estimates. While multiple myeloma remains incurable, new drugs have extended median survival rates from two or three years to between seven and 10 years over the past decade, according to Dana-Farber’s Richardson.