Europe's Committee for Medicinal Products for Human Use (CHMP) did not recommend approval for oral ixazomib for patients with relapsed/refractory multiple myeloma (MM), citing insufficient clinical benefit.
The U.S. Food and Drug Administration approved ixazomib last year in combination with lenalidomide and dexamethasone for MM patients who have received at least one prior therapy.
The submission for approval both in the United States and abroad was based on the results of the TOURMALINE-MM1 trial that compares the use of ixazomib versus placebo in combination with lenalidomide and dexamethasone in relapsed/refractory MM patients.
Other trials investigating ixazomib in combination with other therapies for MM and light chain amyloidosis are ongoing.
Takeda, the drug's manufacturer, said it will appeal CHMP's opinion.
Source: Business Wire, May 27, 2016.