FDA Approves Imbruvica (Ibrutinib) for Chronic Lymphocytic Leukemia

The US Food and Drug Administration has approved the use of Imbruvica (ibrutinib) to treat some people with chronic lymphocytic leukemia (CLL). The drug is intended for patients whose cancer has progressed or come back after at least one other treatment. Ibrutinib was granted “breakthrough therapy” status, which qualified it for faster FDA review. It was first approved last November for some people with mantle cell lymphoma.

CLL is a type of cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. CLL starts from lymphocytes in the bone marrow.

Ibrutinib is a type of targeted therapy that works by interrupting some of the cellular signals that are needed for the cancer to develop and keep growing. It is taken by mouth once a day.

The FDA approval is based on a study of 48 CLL patients whose leukemia had come back or was no longer responding to other drugs. 58% of them responded to ibrutinib.

So far ibrutinib has been shown to have fewer side effects than most standard chemotherapy drugs, although it can still cause serious side effects in some people. The most common side effects in the study were low levels of platelets in the blood, diarrhea, bruising, a decrease in infection-fighting white blood cells, low red blood cells, upper respiratory tract infection, fatigue, pain in the muscles and bones, rash, fever, constipation, swelling of tissues, joint pain, nausea, mouth sores, sinus infection, and dizziness.

Imbruvica is manufactured by Pharmacyclics.

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