FDA Approves Ninlaro (Ixazomib) for Multiple Myeloma

The US Food and Drug Administration (FDA) has approved the third drug this year for treating multiple myeloma, a type of cancer that starts in plasma cells. Ninlaro (ixazomib) is a targeted therapy drug approved to be given in combination with two other drugs – lenalidomide and dexamethasone. This combination is the first all-oral regimen for treating multiple myeloma. It’s intended for people who have received at least one previous treatment.

The FDA based its approval on a clinical trial of 722 people with multiple myeloma that didn’t get better with treatment, or came back after treatment. The people who were given the 3-drug combination went an average 20.6 months without their cancer getting worse compared with 14.7 months for the people who were given lenalidomide and dexamethasone without Ninlaro.

Ninlaro was given priority review, one of the ways in which the FDA tries to speed up availability of drugs to treat serious diseases. Under priority review, the FDA tries to make a decision within 6 months instead of the usual 10 months. Ninlaro was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases.

The most common side effects of Ninlaro are diarrhea, constipation, nausea, vomiting, back pain, low levels of platelets in the blood (increasing the risk of bleeding), swelling in the legs and feet, and nerve damage that can cause weakness, numbness and pain in the hands or feet.

Ninlaro is marketed by Takeda Pharmaceuticals.

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