FDA Approves Ibrutinib for Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) has approved ibrutinib (Imbruvica) to treat some people with mantle cell lymphoma. The drug is intended for patients who have stopped responding to treatment, or whose cancer has come back after treatment. Ibrutinib was granted “breakthrough therapy” status, which qualified it for faster FDA review.

“Imbruvica’s approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement. “The agency worked cooperatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the Breakthrough Therapy Designation program.”

Ibrutinib is a type of targeted therapy that works by interrupting certain parts of the cellular changes and signals that are needed for a cancer to develop and keep growing. Ibrutinib is taken by mouth once a day. So far side effects have been less severe than for most standard chemotherapy drugs.

Mantle cell lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. Lymphocytes are in the lymph nodes and other lymphoid tissues. Mantle cell lymphoma is usually widespread at the time it is diagnosed, and it often doesn’t respond well to treatment. A new drug to treat it is significant, because there are few other effective treatments currently available.

Approval was based on a study of 111 mantle cell lymphoma patients whose disease had come back or was no longer responding to other treatments. Of the patients studied, 75 of them responded to ibrutinib, meaning the lymphoma shrank. The responses lasted for an average 17 months.  Of these patients, 23 had a complete response, meaning all signs of the cancer disappeared. The most common side effects were mild or moderate diarrhea, fatigue, and nausea.

Ibrutinib is marketed by Pharmacyclics and Biotech, Inc.

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