FDA Approves New Multiple Myeloma Drug

Ninlaro (ixazomib), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat people with multiple myeloma who have had at least one prior treatment with a different therapy.

Multiple myeloma is a type of cancer that forms in infection-fighting white blood cells produced in bone marrow. Symptoms include a weakened immune system and bone and kidney problems.

Ninlaro, from a class of drugs called proteasome inhibitors, is designed to block enzymes that spur the growth and survival of multiple myeloma cells, the FDA said Friday in a news release.Almost 27,000 cases of multiple myeloma will be diagnosed in the United States this year, and more than 11,000 people are projected to die from it, the FDA said, citing the National Cancer Institute.

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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 people. 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, low blood platelets, nerve damage of the hands and feet, nausea/vomiting and back pain.

Ninlaro, the third multiple myeloma drug approved by the FDA this year, is produced by the Japanese drugmaker Takeda Pharmaceuticals.