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FDA Agrees to Review Application for Ibrutinib (Imbruvica) for Treatment of Macroglobulinemia

Approval decision expected in April 2015

The FDA has provided a Prescription Drug User Fee Act (PDUFA) target date of April 17, 2015, by which time the agency plans to finalize its review of a supplemental new drug application for ibrutinib (Imbruvica, Pharmacyclics/Janssen Biotech) as a treatment for patients with Waldenstrom’s macroglobulinemia (WM), a type of non-Hodgkin lymphoma.

            Ibrutinib is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell–receptor signaling complex that plays an important role in the survival and spread of malignant B cells. Ibrutinib blocks signals that tell malignant B cells to multiply and spread uncontrollably.

            Ibrutinib is currently approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost.

            Ibrutinib is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Improvements in survival or disease-related symptoms have not been established. Continued approval for the MCL indication may be contingent upon verification of a clinical benefit in confirmatory trials.

            Ibrutinib is being studied alone and in combination with other treatments in several blood cancers. More than 4,600 patients have been treated in clinical trials of ibrutinib conducted in 35 countries. In addition, 13 phase III trials have been initiated with ibrutinib.

            WM cells grow mainly in the bone marrow, where they produce large amounts of immunoglobulin M antibodies (macroglobulins). The buildup of these proteins in the body can lead to the symptoms of WM, including excessive bleeding, problems with vision, and nervous-system problems.

                Sources: Pharmacyclics, Inc.; December 22, 2014; and American Cancer Society; October 21, 2014.

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