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November 20, 2015

On November 20, 2015, the U.S. Food and Drug Administration approved ixazomib (NINLARO®, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor.

The approval was based on an improvement in progression- free survival (PFS) in a multicenter, randomized, double-blind, placebo-controlled trial enrolling 722 patients with multiple myeloma who had received 1 to 3 prior lines of therapy. Patients were randomized in a 1:1 ratio to either the combination of ixazomib, lenalidomide and dexamethasone (n=360) or the combination of placebo, lenalidomide and dexamethasone (n=362). Patients continued treatment until disease progression or unacceptable toxicity.

The trial showed a statistically significant improvement in PFS. The median PFS on the combination arm of ixazomib, lenalidomide and dexamethasone was 20.6 months (95% CI: 17.0, NE) compared to a median PFS of 14.7 months (95% CI: 12.9, 17.6) on the combination arm of placebo, lenalidomide and dexamethasone (PFS HR 0.74, 95% CI: 0.59, 0.94; p value=0.012).

The more common (>20%) adverse reactions associated with an increased rate on the ixazomib combination arm compared to the placebo combination arm were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.

The recommended starting dose of ixazomib is 4 mg orally on days 1, 8, and 15 of a 28 day cycle in combination with lenalidomide 25 mg daily on days 1 through 21 and dexamethasone 40 mg on days 1, 8, 15, and 22 of a 28 day treatment cycle.

This application was approved before its Prescription Drug User Fee Act (PDUFA) date of March 10, 2016. The application was granted Priority Review. A description of expedited review programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at:

Full prescribing information is available at:

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).