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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.

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