Forum members from Canada will be pleased to hear that a regulatory submission has been made to have Health Canada approve Ninlaro (ixazomib) as a new treatment for multiple myeloma.
We have a copy of the press release here:
"Takeda's New Drug Submission For Ixazomib, A New Treatment For Patients With Relapsed And/Or Refractory Multiple Myeloma, Is Accepted For Priority Review By Health Canada," Takeda Canada press release, issued Feb 16, 2016
Here are a few excerpts from the press release:
The New Drug Submission (NDS) for Takeda’s ixazomib has been accepted for priority review by Health Canada. Ixazomib is the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. If approved, ixazomib will be the first oral proteasome inhibitor available in Canada, helping meet the urgent needs of patients living with multiple myeloma, a devastating, relapsing and incurable rare cancer. With once-weekly oral dosing, ixazomib enables the first all-oral triplet regimen including both a proteasome inhibitor and an immunomodulator for the treatment of relapsed and/or refractory multiple myeloma.
Health Canada may grant Priority Review status for drug submissions indicated for the treatment of a severely debilitating disease or condition wherein there exists an unmet medical need or for which a substantial improvement in the benefit/risk profile of the therapy is demonstrated ...
The NDS for ixazomib was primarily based on the results of the final analysis of the pivotal Phase 3 trial, TOURMALINE-MM1. This study is an international, randomized, double-blind, placebo controlled clinical trial of 722 patients designed to evaluate the superiority of ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Patients continue to be treated to progression in this trial and will be evaluated for long-term outcomes.
