The US Food and Drug Administration has agreed to undertake a priority review of Takeda’s ixazomib, the first investigational oral proteasome inhibitor for the treatment for multiple myeloma.

The submission is based on data from the pivotal TOURMALINE-MM1 trial, interim analysis of which showed 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.

Takeda is hoping that its drug will offer a meaningful treatment advance; proteasome inhibition is already a mainstay in MM treatment, but is only currently available in intravenous or subcutaneous formulations, which can prove challenging for patients.

Regulators in Europe are also undertaking an accelerated review of ixazomib for the treatment of patients with relapsed and/or refractory MM, and the drug carried orphan status on both sides of the Atlantic.