FDA Grants Priority Review to Ixazomib for Multiple Myeloma
The FDA has granted Priority Review status to Takeda’s New Drug Application (NDA) for ixazomib.
Ixazomib is the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.
“We are encouraged that both the US and European regulatory bodies have determined that the ixazomib applications qualify for an expedited review, underscoring the importance of new treatment options for patients with relapsed/refractory multiple myeloma,” said Melody Brown, Vice President of Regulatory Affairs, Takeda. “Our ixazomib programme is designed to evaluate whether sustained therapy with an oral proteasome inhibitor improves the outcomes of patients living with multiple myeloma. There is a significant unmet medical need in multiple myeloma and we look forward to working with the regulatory bodies to bring ixazomib to patients.”
The FDA may grant Priority Review status, which includes expedited review, to the evaluation of applications for drugs that treat a serious condition and would provide a significant improvement in safety or efficacy over existing treatment. Ixazomib was recently granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The NDA submission for ixazomib was primarily based on the results of the first pre-specified interim analysis of the pivotal Phase 3 trial, TOURMALINE-MM1. This study is an international, randomised, 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.