Pharmacyclics Files Supplemental New Drug Application for IMBRUVICA® for Waldenstrom's Macroglobulinemia

SUNNYVALE, Calif., Oct. 20, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) 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 2 study evaluating the use of IMBRUVICA® (ibrutinib) in patients with Waldenstrom's macroglobulinemia (WM), which was led by Dr. Steven Treon from the Dana-Farber Cancer Institute. IMBRUVICA, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.