Ixazomib promising for treatment-resistant multiple myeloma6 Dec 2015
Results from the TOURMALINE-MM1 trial showed that treatment with ixazomib capsules is effective in extending progression-free survival with a manageable tolerability profile in patients with relapsed and/or refractory multiple myeloma.
Clinical data leading to the FDA approval
The TOURMALINE-MM1 trial is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate once-weekly oral ixazomib plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone.
Ixazomib was recently approved by the U.S. FDA in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. The approval was based on this Phase 3 TOURMALINE-MM1 data.
More data will be gathered in order to expand the drug’s safety profile
“The breadth and depth of the TOURMALINE program allows us to gather important data across a broad range of patients that live with multiple myeloma and to expand on the efficacy and safety profile of our oral proteasome inhibitor, ixazomib.” said Andy Plump, M.D., Ph.D, Takeda Chief Medical and Scientific Officer.
“Research has shown that the combination of a proteasome inhibitor with cyclophosphamide and dexamethasone is active in patients with multiple myeloma. As treatment practices for multiple myeloma can vary across regions, it is important that we gain an understanding of the utility of ixazomib in a number of combination settings,” said Meletios A. Dimopoulos, M.D., National and Kapodistrian University of Athens, School of Medicine. “Preliminary data suggest that this may be a viable all-oral triplet regimen. We are committed to gathering additional data of ixazomib in this investigational setting.”Source: eCancer News