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Boehringer Ingelheim Pharmaceuticals, Inc. Announces Afatinib Expanded Access Program (EAP) for Patients With EGFR Mutation-Positive Advanced NSCLC


9/14/2012 11:06:55 AM

RIDGEFIELD, Conn., Sept. 13, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the company has initiated an open-label, U.S. multi-center expanded access program (EAP) for its investigational, oncology compound, afatinib.1 The EAP will be available to eligible patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have an epidermal growth factor receptor (EGFR) mutation.1 Healthcare professionals and patients can learn more about the afatinib EAP by calling +1 855-EAP-BIPI (855-327-2474) or by visiting clinicaltrials.gov. Afatinib is an investigational therapy and has not been approved by the U.S. Food and Drug Administration (FDA).

Under certain circumstances, the FDA allows companies in the late stages of drug development to offer early access programs of investigational compounds, such as afatinib. These programs are specifically for those patients who are not eligible to enroll in a clinical trial and who have serious or immediately life-threatening illnesses for which there are no comparable or satisfactory alternate therapies.2

"Patients with EGFR mutation-positive advanced NSCLC currently have limited treatment options," said Berthold Greifenberg, MD, vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "Boehringer Ingelheim has chosen to initiate this EAP because of its commitment to these patients. This program will provide eligible patients with early access to afatinib and we are currently working rapidly to prepare and submit a new drug application to the FDA."

About the Afatinib EAP

The afatinib EAP (clinical trial identifier NCT01649284) is an open-label, multi-center trial for patients with locally advanced or metastatic NSCLC who have an EGFR mutation.1 Patients not previously treated with an EGFR targeted therapy as well as those previously treated with these agents may be eligible for the afatinib EAP. As a single-arm trial, afatinib will not be compared to another anti-cancer therapy.1 Enrollment criteria are available on clinicaltrials.gov and include patients with:1

  • Locally advanced or metastatic NSCLC1
  • Positive test for EGFR mutation(s)1
  • Performance status between 0 and 21

Afatinib is not approved by the FDA; its safety and efficacy have not been established.

About Boehringer Ingelheim in Oncology

Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to develop innovative cancer treatments. Working in close collaboration with the international scientific community and a number of the world's leading cancer centers, Boehringer Ingelheim's commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers. The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition.

If you or someone you know is interested in participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com. If you are a healthcare provider and are interested in learning more about BI clinical trials in oncology, please visit www.inoncologyus.com for additional information.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

References

[1] Afatinib Expanded Access Program. Available at: http://clinicaltrials.gov/ct2/show/NCT01649284?term=afatinib+EAP&rank=1. Accessed July 24, 2012.
[2] 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. Last accessed July 25, 2012.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.



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