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Ibrutinib Phase 2 Study Results in Patients with Mantle Cell Lymphoma 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 of a Phase 2 study evaluating the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) online. These data suggested ibrutinib may be effective and generally well-tolerated in patients with relapsed/refractory MCL.

Results of a separate study examining the safety and efficacy of ibrutinib monotherapy for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), some of whom had deletion of part of chromosome 17 (del 17p), has also been published online by The NEJM. Pharmacyclics sponsored both studies and is jointly developing ibrutinib with Janssen Research & Development, LLC.

"There remains a significant unmet need for patients with MCL," said lead author Michael Wang, M.D., Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center. "These data are exciting because they demonstrate that the longer MCL patients are treated with ibrutinib the better they respond to the treatment."

The study evaluated 111 patients with relapsed/refractory MCL treated with ibrutinib. The majority of patients (86 percent) had intermediate or high-risk MCL and had previously undergone treatment with a median of three prior therapies before enrollment in the study. Patients were enrolled in two cohorts based on whether they had prior exposure to bortezomib. Overall response rate across both cohorts was 68 percent with 47 percent of patients achieving a partial response and 21 percent achieving a complete response where all signs of cancer
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SOURCE Pharmacyclics, Inc.
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Related medicine technology :

1. Ibrutinib Study Results in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Published in The New England Journal of Medicine
2. Updated Results of Two Phase 2 Ibrutinib Studies in Patients with Mantle Cell Lymphoma or Diffuse Large B-cell Lymphoma
3. Ibrutinib Phase 2 Data: Analyses Show Efficacy with Ibrutinib Monotherapy in Patients with Relapsed or Refractory Mantle Cell or Diffuse Large B-cell Lymphoma
4. Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma
5. Phase II Ibrutinib Monotherapy Study Shows CLL Patients Achieved Rapid and Sustainable Disease Control Irrespective of Age or High Risk Prognostic Factor
6. Pharmacyclics Announces Third Breakthrough Therapy Designation for Ibrutinib from the U.S. Food and Drug Administration
7. Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from U.S. Food and Drug Administration
8. 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
9. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
10. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
11. Pharmacyclics Announces Oral Presentations and Clinical Update of Ibrutinib (PCI-32765) at the 2012 Annual Meeting of the American Society of Clinical Oncology
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