The U.S. Food and Drug Administration (FDA) granted approval for ixazomib (Ninlaro) in combination with two other agents to treat patients with multiple myeloma who have received at least one prior therapy.
“As we learn more about the underlying biology of multiple myeloma, we are encouraged to see the development of new ways to treat this disease,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval is the third drug for multiple myeloma approved this year and provides patients with a new oral treatment that slows disease progression when other therapy has failed.” The FDA approved panobinostat (Farydak) in February and daratumumab (Darzalex) earlier in November.
Ixazomib is a proteasome inhibitor that works by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive. Ixazomib is the first oral proteasome inhibitor and is approved in combination with another FDA-approved treatment for multiple myeloma, lenalidomide (Revlimid), plus the corticosteroid dexamethasone.
Clinical Study Details
The safety and efficacy of ixazomib were demonstrated in an international, randomized, double-blind clinical trial of 722 patients whose multiple myeloma did not respond to one to three previous treatments. Study participants received either ixazomib in combination with lenalidomide and dexamethasone, or placebo plus lenalidomide and dexamethasone. Those taking ixazomib showed a significant improvement in progression-free survival (average, 20.6 months) compared to participants taking the other regimen (14.7 months).
The most common side effects of ixazomib are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.
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