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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

ites internationally, and 86 percent of patients had intermediate or high-risk MCL. Study participants received a 560mg daily oral dose of ibrutinib monotherapy and were treated into two cohorts based on prior exposure to bortezomib – either no prior bortezomib (n=63) or prior bortezomib (n=48). Overall, patients had received a median of three prior therapies.

About Mantle Cell Lymphoma
MCL, a B-cell malignancy, is an aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually occurs in older adults. The disease typically begins in the lymph nodes but can spread to other tissues, such as bone marrow and liver. Ibrutinib targets the B-cell receptor pathway an important pathway in malignant B-cell growth and proliferation. In the United States there are approximately 5,000 new cases of MCL each year.

About Ibrutinib
Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel —regulation of apoptosis, cell adhesion, and cell migration and homing.

The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Waldenstrom's macroglobulinemia and multiple myeloma. To date six Phase 3 trials have been initiated with ibrutinib and a total of 30 trials are currently registered on www.clinicaltrials.gov. Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib.

About Pharmacyclics
Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commerciali
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SOURCE Pharmacyclics, Inc.
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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
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7. Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from U.S. Food and Drug Administration
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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
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