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

RARITAN, N.J., May 6, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the United States for the investigational oral Bruton's Tyrosine Kinase (BTK) inhibitor ibrutinib, which is being jointly developed by Janssen and Pharmacyclics, Inc. Several EAP sites are in the process of opening the clinical trial and information about the program is posted on clinicaltrials.gov (NCT01833039). The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinib prior to U.S. Food and Drug Administration (FDA) approval.

Interested patients with MCL should discuss the option of accessing ibrutinib through the EAP with their physician to understand if this is an appropriate option for them.

"We recognize there are immediate medical needs of certain individuals with relapsed or refractory MCL," said Peter F. Lebowitz , M.D., Ph.D., Global Oncology Head, Janssen. "Now that the ongoing U.S. clinical studies in relapsed or refractory MCL have completed enrollment, the expanded access protocol provides that opportunity."

The ibrutinib expanded access program was agreed upon in collaboration with the FDA as part of ibrutinib's breakthrough therapy designation for relapsed/refractory MCL granted by the FDA in February 2013. EAPs are allowed by the FDA under certain circumstances even though the safety and effectiveness of the drug have not been fully established. Expanded access programs provide a mechanism for early access to an investigational drug in the pre-approval period to treat patients with a serious or immediately life-threatening disease or condition that has no comparable or satisfactory alternative treatment options.[1]

About the 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, 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 & Development and Janssen Biotech are part of the Janssen Pharmaceutical Companies. Please visit http://www.janssenrnd.com for more information.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

[1] The U.S. Food and Drug Administration. Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access). Available at: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm.

Media Inquiries:
Kellie McLaughlin
Phone: 1-908-927-7477
Mobile: 1-609-468-8356

Investor Relations:
Stan Panasewicz
Phone: 1-732-524-2524

Louise Mehrotra
Phone: 1-732-524-6491


'/>"/>
SOURCE Janssen Research & Development, LLC
Copyright©2012 PR Newswire.
All rights reserved

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. Delcath To Offer Second Generation Hemofiltration Cartridge In U.S. Expanded Access Program
9. Boehringer Ingelheim announces afatinib expanded access program (EAP) for patients with EGFR mutation-positive advanced NSCLC
10. Elusys Awarded Additional $14.5 Million Under Existing U.S. Government Contracts Supporting Expanded Human Safety Studies of ETI-204 for Treatment of Inhalational Anthrax
11. CombiMatrix Corporation Selects Cartagenia BENCHlab CNV Platform to Bolster Expanded Lab Operations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  Consumers have taken ... regulators/payers have placed more emphasis on patient outcomes. ... support programs in the pharmaceutical industry have evolved ... Consequently, pharmaceutical companies are focusing on becoming more ... providing products and services that improve health. ...
(Date:6/24/2016)... Research and Markets has ... 2015-2025: Applications, Technologies, Forecasts" report to their ... Electronics, Smart Skin, Structural Health Monitoring, Composite Smart ... electronics involves electronic and/or electrical components and circuits ... structures such as vehicle bodies or conformally placed ...
(Date:6/24/2016)... 2016 According to a new ... Pen Needles, Safety Pen Needles), Needle Length (4mm, 5mm, ... Mode of Purchase (Retail, Non-Retail) - Trends & Global ... the market for the forecast period of 2016 to ... Billion by 2021 from USD 1.65 Billion in 2016, ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal ... personalized through a fitness app. The fitness app plans to fix the two major problems ... offer a one size fits all type program , They don’t eliminate all ...
(Date:6/25/2016)... Washington, D.C. (PRWEB) , ... June 25, 2016 ... ... will discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June ... share their work on several important health care topics including advance care planning, ...
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... ... 2016 , ... First Choice Emergency Room , the largest network of ... Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased to ... said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has dedicated ... has implemented orthobiologic procedures as a method for treating his patients. The procedure ... doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to ...
Breaking Medicine News(10 mins):