Takeda’s experimental multiple myeloma drug ixazomib has cleared another key regulatory hurdle after its marketing application was accepted for review by the European Medicines Agency.

The once-weekly drug is an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory forms of the cancer, which was granted an accelerated assessment by the Committee for Medicinal Products for Human Use last month.

The filing is based on interim data from the Phase III trial Tourmaline-MM1 trial involving 722 patients, showing 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.

Ixazomib has also received breakthrough therapy status in the US as well as orphan drug designation from both the FDA and EMA.