The United States Food and Drug Administration (FDA) has granted approval to Ninlaro® (ixazomib) for the treatment of multiple myeloma. This marks the third drug approved this year for the treatment of multiple myeloma.
The approval specifies that Ninlaro is to be used in addition to two other agents, Revlimid (lenalidomide) and dexamethasone, to treat patients with multiple myeloma who have received at least one prior therapy.
Ninlaro is referred to as a proteasome inhibitor. It produces anti-cancer effects by blocking proteins called enzymes within myeloma cells. By blocking these enzymes, the growth of the cancer cells is reduced or halted.
Multiple myeloma is a type of cancer that affects certain immune cells called plasma cells. The National Cancer Institute estimates that approximately 27,000 new cases of multiple myeloma will be diagnosed, and 11,240 deaths will be caused by the disease this year in the United States.
The trail leading to the approval of Ninlaro included 722 patients with multiple myeloma whose cancer returned or progressed following prior therapy. Patients were divided into two groups: one group was treated with Ninlaro plus lenalidomide/dexamethasone, and the other group was treated with placebo (inactive substitute), plus lenalidomide/dexamethasone. Results from the two groups were directly compared.
- The average time before multiple myeloma started to progress following treatment on the trial was 20.6 months for the group treated with Ninlaro, compared with 14.7 months for those treated with placebo.
- The most common side effects associated with Ninlaro were diarrhea, constipation and low platelet levels.
In the FDA’s news release announcing the approval of Ninlaro, Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research stated, “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. 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.”
Reference: United States Food and Drug Administration (FDA). FDA news release. FDA approves Ninlaro, new oral medication to treat multiple myeloma. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473771.htm. Accessed November 20, 2015.
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