FDA approves Imbruvica to treat rare form of non-Hodgkin lymphoma

WASHINGTON - Jan. 30, 2015 - PRLog -- J & J's Imbruvica has been cleared for expanded approval by the U.S. Food and Drug Administration to treat patients with Waldenström’s macroglobulinemia (WM), a rare cancer that originates in the body’s immune system. Imbruvica blocks the enzyme that allows the abnormal B-cells in WM to grow and divide.  “Today’s approval highlights the importance of development of drugs for supplemental indications,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Continued research has discovered new uses of Imbruvica.”

Approval of Imbruvica for WM was based on a clinical study involving 63 participants who received 420 milligram dose of the medication until disease progression or side effects became intolerable. According to the results, 62 percent of the participants had their cancer shrink after treatment.

Waldenström’s macroglobulinemia (WM) is a type of non-Hodgkin lymphoma which slowly worsens over time and causes B-lymphocytes (B-Cells) to grow within the bone marrow, lymph nodes, liver, and spleen. These abnormal blood cells (B-cells) overproduce a protein known as immunoglobulin M or IgM (macroglobulin) which causes excess bleeding, and affects the vision and nervous system.

Imbruvica is already approved for use in patients with cell lymphoma who received one prior therapy, patients with previously treated chronic lymphocytic leukemia (CLL) and for CLL patients who carry a deletion in chromosome 17. The approved use for Waldenström’s macroglobulinemia (WM) received breakthrough therapy designation from the FDA. Imbruvica is being jointly developed and commercialized by Janssen and Pharmacyclics, Inc.

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