New York, NY (August 27, 2018) – The U.S. Food and Drug Administration (FDA) announced it has approved the use of ibrutinib (IMBRUVICA) plus rituximab (RITUXAN) for the treatment of adult patients with Waldenström macroglobulinemia (WM). This approval represents the first and only chemotherapy-free combination treatment specifically indicated for the disease. Ibrutinib was first approved as a single agent therapy for WM in 2015.
“Today’s approval represents a major advancement to the frontline standard of care for people with Waldenström macroglobulinemia,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “This is a first of its kind approval for patients who now have a chemotherapy-free treatment.”