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Ed Forum 2016 SGL

US FDA Approves Imbruvica-Rituximab Combination Therapy for WM

Aug 27, 2018

The IWMF is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the combination treatment of Imbruvica (ibrutinib) together with Rituximab (rituxan) for patients living with Waldenstrom’s macroglobulinemia.  (Pharmacyclics had filed a supplemental New Drug Application with the FDA on June 25, 2018 for priority review for the combination treatment.)

In 2015, Imbruvica (ibrutinib) became the first treatment option approved specifically for WM – first in the US in January, and later that year in the European Union, followed by the UK in 2017.  As a single-agent therapy, Imbruvica is the first and only FDA-approved treatment available for patients with WM.

Carl Harington, President of the IWMF, stated the following: “We are excited to see strides being made for patients living with Waldenstrom’s macroglobulinemia, a rare blood cancer with limited options.  We are grateful for the commitment and research led by Janssen and Pharmacyclics, along with researchers across the globe who are dedicated to people living with WM.”

The IWMF is excited to see the continued research and clinical trial focus on finding additional treatment options specifically for WM, and sees this announcement as further proof that those efforts are beginning to pay off for WM patients around the world. 

While this is a cause for celebration, we still have not achieved a cure, and not every patient with WM may respond to the treatment.  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 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 press releases from AbbVie.  The US FDA official press release is not yet available.

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