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Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma
Date:5/6/2013

Ibrutinib Expanded Access Protocol
The ibrutinib mantle cell lymphoma (MCL) EAP is for patients who meet specific eligibility criteria, which includes patients 18 years of age or older with relapsed or refractory MCL who may benefit from treatment with ibrutinib prior to FDA approval. The EAP has specific inclusion and exclusion criteria which must be met in order to be eligible for enrollment in the program. Patients should contact their physician to discuss the option of accessing ibrutinib through the EAP. Information about the expanded access treatment protocol is posted on clinicaltrials.gov (NCT01833039).

About Mantle Cell Lymphoma
Mantle cell lymphoma 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 the 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 is a Bruton's tyrosine kinase (BTK) inhibitor. The effectiveness and safety of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies.

Janssen Biotech, Inc. and Pharmacyclics entered 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 2013. 

About Janssen Research & Development
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, i
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SOURCE Janssen Research & Development, LLC
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