Pharmacyclics, Inc. today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based on data from a Phase II study evaluating the use of Imbruciva (ibrutinib) in patients with Waldenstrom's macroglobulinaemia (WM), which was led by Dr. Steven Treon from the Dana-Farber Cancer Institute. Imbruciva, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclicsand Janssen Biotech, Inc.

WM is a slow-growing, currently incurable, rare type of B-cell lymphoma for which no established standard of care - or approved therapeutic - exists. There are approximately 1,000 to 1,500 new cases each year and a prevalence of 12,000 in the United States, and the median age at diagnosis is 60 to 70 years of age. WM begins with a malignant change to the B cell, a type of white blood cell (lymphocyte), during its maturation so that it continues to reproduce more malignant B-cells. WM cells make large amounts of a certain type of antibody (immunoglobulin M, or IgM), which is known as a macroglobulin. Each protein made by the WM cells is the same, so it is called a monoclonal protein, or just an M protein.

"Over the past five years, we have worked diligently on the clinical development for the use of IMBRUVICA in Waldenstrom's macroglobulinemia patients. Today marks an important milestone for these patients," said Thorsten Graef, M.D., PhD, Vice President of Clinical Science, Pharmacyclics. "Our supplemental New Drug Application for this underserved patient population and our ongoing Phase III study reinforce our commitment to developing novel therapies that address serious unmet medical needs."

For more details, go to: http://ir.pharmacyclics.com/releasedetail.cfm?ReleaseID=876945