The U.S. Food and Drug Administration (FDA) has approved ixazomib (Ninlaro), an oral proteasome inhibitor, in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.1
“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.
Approval was based on the findings from an international, double-blind clinical trial of 722 patients with relapsed and/or refractory multiple myeloma. Participants were randomly assigned to receive ixazomib or placebo in combination with lenalidomide and dexamethasone.
Results showed that median progression-free survival was 20.6 months for the ixazomib group compared with 14.7 months with placebo.
In regard to safety, the most common adverse events of ixazomib were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.
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“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,” Dr. Pazdur said.
The National Cancer Institute estimates that there will be approximately 26 850 new cases of multiple myeloma in the United States in 2015 and about 11 240 multiple myeloma-related deaths.
- FDA approves Ninlaro, new oral medication to treat multiple myeloma [news release]. Silver Spring, MD: U.S. Food and Drug Administration; November 20, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473774.htm. Accessed November 20, 2015.