The European Medicines Agency (EMA) has accepted the authorisation for the use of ixazomib for treating relapsed and/or refractory multiple myeloma.
Ixazomib is an investigational oral proteasome inhibitor and had previously been granted accelerated assessment by the Committee for Medicinal Products for Human Use due to it being a therapeutic innovation.
In addition to the ixazomib submission with the EMA, a new drug application was filed with the US Food and Drug Administration. Additional filings in other countries are planned to begin later this year.
The submission to the EMA was based on the results of the first pre-specified interim analysis of the pivotal Phase 3 trial TOURMALINE-MM1, 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.
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of plasma cells, or myeloma cells, becomes cancerous and multiply, increasing the number of plasma cells to a higher than normal level. As plasma cells circulate widely in the body, they have the potential to affect many bones in the body, potentially resulting in compression fractures, lytic bone lesions and related pain.
It can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anaemia.
Multiple myeloma is a rare form of cancer with about 39,000 new cases in the EU and 114,000 globally per year.