Ixazomib Approved by FDA for Multiple Myeloma Treatment
US Food and Drug Administration
(HealthDay News) -- Ninlaro (ixazomib), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat patients with multiple myeloma who have had at least one prior treatment with a different therapy.
Ninlaro, a proteasome inhibitor, is designed to block enzymes that spur the growth and survival of multiple myeloma cells, the FDA said Friday in a news release. Ninlaro is approved in combination with another multiple myeloma drug, Revlimid (lenalidomide), and the corticosteroid drug dexamethasone.
The drug combination was evaluated in clinical studies involving 722 patients. Those who took Ninlaro in tandem with the other two drugs lived for more than 20 months without their disease progressing, compared with about 14 months among those who took a placebo and the other two drugs, the FDA said. Side effects of Ninlaro included diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea/vomiting, and back pain.
"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," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.
Ninlaro is produced by the Japanese drug maker Takeda Pharmaceuticals.