Takeda has submitted an application in the US to market its experimental cancer drug ixazomib for the treatment of patients with relapsed and/or refractory multiple myeloma.
Ixazomib is an investigational oral proteasome inhibitor - the first to enter Phase III trials - which is being studied in MM, systemic light-chain amyloidosis and other malignancies.
This first global submission for the drug 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.
Proteasome inhibition is already an essential component of MM treatment but, as Paul Richardson, Clinical Program Leader and Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center, notes, “there are logistical challenges for patients with both intravenous and subcutaneous approaches, and especially in the absence of an effective oral option”.
If approved, ixazomib “should provide a very meaningful advance for our patients,” given its its convenient once-a-week oral administration and promising efficacy, he said.
Ixazomib carries orphan drug designation in both the US and Europe for MM.