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Pharmacyclics Files Supplemental New Drug Application For IMBRUVICA With Phase III CLL Study Data

Stocks in this article: PCYC

SUNNYVALE, Calif., April 8, 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 the randomized, multi-center, open-label Phase III RESONATE TM study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA TM (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

At a planned interim analysis in January 2014, the results of the RESONATE study demonstrated a statistically significant improvement in progression-free survival, the primary endpoint of the study, in patients treated with IMBRUVICA. Further, patients in the IMBRUVICA arm also showed a statistically significant improvement in overall survival, a key secondary endpoint of the trial. The safety profile of IMBRUVICA was acceptable and showed a favorable risk benefit profile. Data from this study will be discussed in a presentation at the 50 th annual meeting of the American Society of Clinical Oncology in Chicago, May 30June 3, 2014.

"This supplemental new drug application in previously treated CLL patients is our first Phase III submission to the FDA seeking full approval for the use of IMBRUVICA. It is another major milestone in our clinical development plan, which currently includes 10 Phase III studies," said Bob Duggan, CEO and Chairman of the Board of Pharmacyclics. "Our company's mission is to serve as an ally to patients. In the RESONATE study, single agent IMBRUVICA provided a significant benefit for patients with CLL. We look forward to working with the FDA as they review the data from this Phase III study."

The FDA granted an accelerated approval for IMBRUVICA as a single agent for the treatment of patients with MCL or CLL, who have received at least one prior therapy. The accelerated approval for these indications was based on the overall response rate (ORR) of patients in the Phase II clinical studies of PCYC-1102 and PCYC-1104. An improvement in survival or disease-related symptoms was not established in these studies. IMBRUVICA is the first once-daily, single-agent, oral kinase inhibitor for patients with MCL or CLL who have received one prior therapy.

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