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Boehringer Ingelheim announces afatinib expanded access program (EAP) for patients with EGFR mutation-positive advanced NSCLC
Date:9/13/2012

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
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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