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Ed Forum 2017

Historic Day for WMers - US FDA Approves Imbruvica (Ibrutinib) for WM

Jan 29, 2015

In a history-making moment for WM patients, the IWMF is pleased to announce that Imbruvica (ibrutinib) has just received FDA approval specifically for the treatment of WM, thus becoming the first drug therapy to achieve this designation.

Imbruvica, developed jointly by Pharmacyclics and Janssen Biotech Inc., previously received "Breakthrough Therapy Designation" for WM. This expedited its development and review, and Imbruvica had already been approved for patients with chronic lymphocytic leukemia and mantle cell lymphoma. With this new approval and specific designation for use in WM, physicians can now prescribe Imbruvica for all WM patients and many of these patients will be able to obtain better insurance coverage for its cost.

There are many other drugs "in the pipeline," both oral and injectable. Imbruvica is an oral inhibitor of Bruton's tyrosine kinase (BTK) and blocks signals that stimulate malignant B-cells to grow and divide uncontrollably. Pharmaceutical companies are developing treatments that target this and other signaling pathways to provide additional therapy options. As IWMF President Carl Harrington says, "We are thrilled that the scientific and drug development communities are paying attention to Waldenstrom's macroglobulinemia. Rather than receiving treatments that have been developed for other B-cell lymphomas, we are now getting testing and recognition that are specific to our disease."

Pharmacyclics also recently announced that the European Medicines Agency (EMA) has accepted its application for Imbruvica to treat WM patients in Europe. If the application is approved, Imbruvica will also be the first drug specifically authorized for WM in Europe.

While this is certainly a cause for celebration, Imbruvica is not a cure and not every WM patient responds to it. The search continues for curative therapies, and it is important for the IWMF to continue to fund research toward this ultimate goal. We hope that you will join with us, not only in applauding this achievement, but also in working toward a cure for WM.

For more information about this exciting news please see the following press releases from Pharmacylics, Janssen Biotech, Inc., and the FDA.

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