New Multiple Myeloma Rx Gets Go-Ahead

Ninlaro (ixazomib), from Takeda, FDA-approved to treat multiple myeloma

/ Author:  / Reviewed by: Beth Bolt, RPh

(RxWiki News) A new FDA approval could give another option to multiple myeloma patients who haven't had luck with past treatments.

The US Food and Drug Administration (FDA) today approved Ninlaro (ixazomib) to treat multiple myeloma patients who have undergone at least one past treatment without success. The Takeda Pharmaceuticals drug is approved for use in combination with two other multiple myeloma treatments: Revlimid (lenalidomide) and dexamethasone.

The approval of Ninlaro expands on a surge in approved multiple myeloma treatments this year, said Richard Pazdur, MD, director of the FDA's Office of Hematology and Oncology Products.

“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 in a press release.

The FDA approved Farydak (panobinostat) and Darzalex (daratumumab) to treat multiple myeloma earlier this year.

Multiple myeloma is a type of blood cancer. It attacks a type of white blood cell in the bone marrow that helps the body fight infection. The disease can lead to kidney and bone problems, as well as a compromised immune system. More than 11,000 multiple myeloma-related deaths will occur in the US this year, according to National Cancer Institute estimates.

Ninlaro, an oral drug, is a part of a drug class called proteasome inhibitors. According to the FDA, it "works by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive."

The new drug appeared safe and effective in a trial of 722 multiple myeloma patients. The patients in this study had undergone past treatments without success. Some patients received Ninlaro with lenalidomide and dexamethasone. Others received lenalidomide and dexamethasone with a placebo, or fake pill. Compared to patients who received the placebo, patients who received Ninlaro lived an average of 5.9 months longer without their multiple myeloma getting worse.

Common side effects of Ninlaro include numbness and pain, nausea, vomiting, diarrhea and low blood platelet count, among others.

Reviewed by: 
Review Date: 
November 20, 2015
Last Updated:
November 23, 2015