Accelerated EU review for Takeda multiple myeloma drug
The EMA has granted accelerated assessment for Takeda’s investigational multiple myeloma drug Ixazomib. Ixazomib is the first oral proteasome inhibitor to reach Phase III trials for multiple myeloma, a rare form of cancer. Accelerated assessment is awarded to drugs that are deemed to be of major public health interest and therapeutic innovation. Ixazomib has also received breakthrough therapy status in the US as well as orphan drug designation from both the FDA and EMA.
The TOURMALINE-MM1 study, found that patients treated with ixazomib plus lenalidomide/dexamethasone lived without their disease worsening for a significantly longer time than those taking the latter two drugs with a placebo.
Philippe Moreau from the University Hospital of Nantes in France commented “If Ixazomib is approved, for the first time physicians will have the option of an all-oral proteasome inhibitor-based regimen for the treatment of multiple myeloma, which could be a real advantage in delivering sustained therapy.”
Takeda says that it expects to submit an EU marketing authorisation application in the coming weeks.