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Multiple Myeloma Drug Ixazomib Submitted for FDA Review
A new drug application (NDA) has been submitted to the FDA for ixazomib (Takeda), an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.
The NDA submission was supported by data from the pivotal phase III TOURMALINE-MM1 trial, an international, randomized, double-blind, placebo-controlled study designed to evaluate the superiority of ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in 722 adult patients with relapsed and/or refractory multiple myeloma. Patients continue to be evaluated for long-term outcomes in this trial.
Ixazomib is being studied in patients with multiple myeloma, amyloid light-chain (AL) amyloidosis, and other malignancies. Ixazomib was granted an “orphan drug” designation for multiple myeloma in 2011 and for AL amyloidosis in 2012. Ixazomib also received “breakthrough therapy” status for relapsed or refractory AL amyloidosis in 2014. It is also the first oral proteasome inhibitor to enter phase III clinical trials. Five global phase III studies are ongoing:
- TOURMALINE-MM1, investigating ixazomib vs. placebo, both in combination with lenalidomide and dexamethasone, in patients with relapsed and/or refractory multiple myeloma
- TOURMALINE-MM2, investigating ixazomib vs. placebo, both in combination with lenalidomide and dexamethasone, in patients with newly diagnosed multiple myeloma
- TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma after induction therapy and autologous stem cell transplant (ASCT)
- TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
- TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. the physician’s choice of selected regimens in patients with relapsed or refractory AL amyloidosis
In multiple myeloma, a group of plasma cells, or myeloma cells, becomes cancerous and multiplies, increasing the number of plasma cells to a higher-than-normal level. Because plasma cells circulate widely in the body, they have the potential to affect the bones, possibly resulting in compression fractures, lytic bone lesions, and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys, and red blood cell count, with symptoms that include bone pain and fatigue. Multiple myeloma is a rare form of cancer, with approximately 20,000 new cases in the U.S. and 114,000 new cases globally per year.
Source: Takeda; July 15, 2015.