Value through InnovationJuly 24 2014
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Boehringer Ingelheim Pharmaceuticals Inc. afatinib expanded access program (EAP) for patients with
EGFR mutation-positive advanced NSCLC

Boehringer Ingelheim’s expanded access program (EAP) for its investigational, oncology compound, afatinib,* is for eligible U.S. patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have an epidermal growth factor receptor (EGFR) mutation.

About the Afatinib EAP
Afatinib is an investigational therapy and has not been approved by the U.S. Food and Drug Administration (FDA). The afatinib EAP (clinical trial identifier NCT01649284) is an open-label, U.S. multi-center trial for patients with locally advanced or metastatic NSCLC who have an EGFR mutation. 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.

Enrollment criteria are available on clinicaltrials.gov and include patients with:

  • Locally advanced or metastatic NSCLC
  • Positive test for EGFR mutation(s)
  • Performance status between 0 and 2

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.

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.

*Afatinib is an investigational agent. Its safety and efficacy have not been established.