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FDA Grants Ixazomib Priority Review in Multiple Myeloma

Silas Inman @silasinman
Published: Wednesday, Sep 09, 2015

Melody Brown

Melody Brown

The FDA has granted a priority review designation to the oral proteasome inhibitor ixazomib (MLN9708) in combination with lenalidomide and dexamethasone as a treatment for patients with relapsed and/or refractory multiple myeloma, according to a statement from the drug's developer, Takeda.

In the maintenance portion of the study, 71% of patients experienced a drug-related adverse (AE) event with ixazomib. Grade 3 AEs occurred in just 2 patients and none experienced a grade 4 AE. The most frequently reported grade 1/2 ixazomib-related adverse events were diarrhea (38%), nausea (14%), extremity pain (14%), anemia (10%), and headache (10%). Peripheral neuropathy was not reported.

“These findings suggest that treatment with single-agent ixazomib, an investigational oral proteasome inhibitor, in the maintenance setting has the potential to extend depth of response for patients following induction therapy,” lead investigator of the phase II study Shaji K. Kumar, MD, from the Mayo Clinic, said when the data were presented. “The future availability of such an agent in the maintenance setting could represent an important addition to the treatment of patients with multiple myeloma.” 

The TOURMALINE clinical trial program contains 4 other phase III studies in addition to MM1. In the MM2 study, the combination of ixazomib, lenalidomide, and dexamethasone is being explored in newly diagnosed patients with multiple myeloma. In earlier settings, the MM3 and MM4 studies are investigating maintenance therapy with ixazomib in patients who have and have not undergone an autologous stem cell transplant.

In addition to multiple myeloma, ixazomib is being evaluated in combination with dexamethasone for patients with relapsed/refractory systemic light-chain (AL) amyloidosis in the phase III TOURMALINE-AL1 trial. In early December 2014, ixazomib was granted a breakthrough therapy designation as a treatment for patients with AL amyloidosis.

Kumar S, Berdeja JG, Niesvizky R, et al. Long-Term Ixazomib Maintenance Is Tolerable and Improves Depth of Response Following Ixazomib-Lenalidomide-Dexamethasone Induction in Patients (Pts) with Previously Untreated Multiple Myeloma (MM): Phase 2 Study Results. Presented at: the 56th Annual Meeting of the American Society of Hematology; December 6-9, 2014; San Francisco, California. Abstract 82.


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