EU CHMP changes opinion on Ninlaro (ixazomib) and recommends approval of drug combination for multiple myeloma - Takeda

The EMA's CHMP recommended granting a conditional marketing authorisation for Ninlaro (ixazomib), from Takeda, in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma. The combination is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. This follows a re-examination of the Committee�s earlier negative opinion. Ninlaro is a new medicine that is taken orally to treat multiple myeloma, and it has an orphan designation.

During the re-examination, the CHMP consulted a group of experts in cancer and considered, among other things, Ninlaro�s safety profile, the fact that it is taken by mouth, and the possibility of the company providing further data on the benefits of the medicine. The CHMP agreed with the expert group�s conclusion that the available data from the main study indicate that Ninlaro improves patients� progression-free survival. As there is some uncertainty regarding the size of the improvement, further confirmatory data will need to be provided by the company as a condition for marketing authorisation.