The EMA has granted accelerated assessment for Takeda’s investigational multiple myeloma drug ixazomib.
Accelerated assessment is awarded to drugs that are deemed to be of major public health interest and therapeutic innovation. Ixazomib is the first oral proteasome inhibitor to reach Phase III trials for multiple myeloma, which is a rare form of cancer with only around 39,000 new cases in the EU per year.
The TOURMALINE-MM1 study, which Takeda’s upcoming submission will be based on, 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.
The drug also has the advantage of convenient once-a-week oral administration.
“Continuous therapy is emerging as a standard of care in multiple myeloma because it has demonstrated improved long-term outcomes,” says Philippe Moreau from the University Hospital of Nantes in France. “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.
Ixazomib has also received breakthrough therapy status in the US as well as orphan drug designation from both the FDA and EMA.