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Ibrutinib Phase 2 Data: Analyses Show Efficacy with Ibrutinib Monotherapy in Patients with Relapsed or Refractory Mantle Cell or Diffuse Large B-cell Lymphoma
Date:6/16/2013

yclics entered into a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib. The regulatory filing for ibrutinib in MCL is expected to be made prior to the end of the third quarter of 2013. Details about the complete ibrutinib clinical program is posted on clinicaltrials.gov.

To date, ibrutinib has been granted three Breakthrough Therapy Designations by the U.S. Food & Drug Administration (FDA) as a monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with deletion of the short arm of chromosome 17 (del17p); patients with relapsed/refractory MCL who have received prior therapy, and in patients with Waldenstrom's macroglobulinemia (WM). The implications of Breakthrough Therapy Designation cannot be determined at this time.

About B-Cell Malignancies
Both MCL and DLBCL are part of a family of blood cancers which originate from malignant B-cells. Unlike healthy B-cells, malignant B-cells ignore signals to die and continue to develop and reproduce in the lymph.[1][2][3] When a malignancy is described as 'relapsed', it means that it has returned after an initial partial or total remission.[4] 'Refractory' refers to cancer that has become resistant to current treatment.[5]

About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & D
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Related medicine technology :

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
6. Pharmacyclics Announces Third Breakthrough Therapy Designation for Ibrutinib from the U.S. Food and Drug Administration
7. Phase II Ibrutinib Monotherapy Study Shows CLL Patients Achieved Rapid and Sustainable Disease Control Irrespective of Age or High Risk Prognostic Factor
8. Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma
9. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
10. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
11. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
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