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Ibrutinib Study Results in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Published in The New England Journal of Medicine
Date:6/19/2013

SUNNYVALE, Calif., June 19, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today announced that The New England Journal of Medicine (NEJM) published results online of a Phase 1b/2 study evaluating the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Ibrutinib was shown to be safe and effective in patients with relapsed/refractory CLL or SLL, even in patients who were at high-risk due to factors such as deletion of part of chromosome 17 (del 17p).

Results of a separate study examining the safety and efficacy of ibrutinib monotherapy for the treatment of relapsed/refractory mantle cell lymphoma (MCL) has also been published online in NEJM today. Pharmacyclics sponsored both studies and is jointly developing ibrutinib with Janssen Research & Development, LLC.

The open-label study reported on 85 patients with relapsed/refractory CLL or SLL. The majority of patients had advanced disease and had previously undergone treatment with several rounds of therapies before enrollment in the study. Approximately one-third of patients enrolled in the study presented with a malignancy carrying del 17p. Patients with del17p typically respond poorly to chemoimmunotherapy, which is the current standard treatment for CLL.

"Patients with CLL and SLL have a great need for new, well tolerated and effective therapies," said lead author John C. Byrd, M.D., Director, Division of Hematology, D Warren Brown Professor of Leukemia Research, The Ohio State University Comprehensive Cancer Center. "These data are particularly exciting, as they demonstrate benefit for high risk CLL and SLL patients, with efficacy consistent across doses and continuing durable r
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SOURCE Pharmacyclics, Inc.
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1. Pharmacyclics Announces Oral Presentations and Clinical Update of Ibrutinib (PCI-32765) at the 2012 Annual Meeting of the American Society of Clinical Oncology
2. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
3. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
4. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual Meeting
5. Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from U.S. Food and Drug Administration
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8. Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma
9. Ibrutinib Phase 2 Data: Analyses Show Efficacy with Ibrutinib Monotherapy in Patients with Relapsed or Refractory Mantle Cell or Diffuse Large B-cell Lymphoma
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