FDA Approves Imbruvica (Ibrutinib) for Waldenstrom Macroglobulinemia

The US Food and Drug Administration has approved Imbruvica (Ibrutinib) for people with Waldenstrom Macroglobulinemia, a kind of non-Hodgkin lymphoma, which is a cancer that begins in immune system cells. Imbruvica had already been approved to treat people with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).

Ibrutinib is a type of targeted therapy. It is called a tyrosine kinase inhibitor. Tyrosine kinases are proteins on or near the surface of a cell that send signals to the cell’s control center. Some of these signals help cancer cells to grow and survive. Ibrutinib blocks these signals, which helps stop cancer cells from growing.

The FDA based its approval on a study of 63 people who had been previously treated for Waldenstrom Macroglobulinemia. Almost two-thirds of them (62%) had their cancer shrink after taking Imbruvica. The FDA approved Imbruvica for the new use under its accelerated approval program for drugs that show promise against a serious disease.

Imbruvica is a pill taken by mouth usually once a day. The most common side effects are low blood platelet or white blood cell counts, anemia, fatigue, pain, bruising, nausea, upper respiratory tract infection, and rash. More serious side effects include a risk for serious bleeding, abnormal heartbeat, development of new cancers, and problems with the kidneys. The drug can cause problems for the fetus if women take it while pregnant.

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