Japan's Takeda Pharmaceutical has submitted a New Drug Application to the U.S. FDA for the use of ixazomib to treat patients with relapsed and/or refractory multiple myeloma, the company said in a press release, marking a milestone for its top oncology prospect.
|Takeda CEO Christophe Weber|
In the May earnings release, Takeda Pharmaceuticals CEO and President Christophe Weber noted Phase III interim results for ixazomib were in, building slightly on an interim analysis released in February that showed ixazomib beat out a placebo in extending progression-free survival for multiple myeloma sufferers who have failed prior treatments.
At the time, the company did not detail data, but did say it would submit the results to regulatory authorities in hopes of an approval for multiple myeloma. The drug is an investigational oral proteasome inhibitor.
In the release, Takeda said ixazomib plus lenalidomide and dexamethasone was compared over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma.
"Patients continue to be treated in this trial and evaluated for long-term outcomes," the release said, adding that "this is the first regulatory submission for ixazomib" and "additional filings are planned to begin in Europe and other countries later this year."
Also in May of this year, the company said it had enrolled its first patient in a global Phase III study of ixazomib as maintenance therapy for newly diagnosed multiple myeloma.
"This submission marks an important step in Takeda's ongoing commitment to innovation for patients living with multiple myeloma," said Andrew Plump, Takeda's chief medical and scientific officer, in a statement.
- here's the release