Navigation Links
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 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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Boehringer Ingelheim and Lilly introduce the My Well Planner Lifestyle Improvement Program for Adults with Type 2 Diabetes
2. Lilly and Boehringer Ingelheim Present Data at the 72nd American Diabetes Association Scientific Sessions® from Phase II Studies Comparing Investigational Novel Basal Insulin to Insulin Glargine
3. Boehringer Ingelheim Presents First Data for Tiotropium in Adolescents with Moderate Persistent Asthma
4. Results of Phase II Study of Boehringer Ingelheims Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference
5. Boehringer Ingelheim to present pivotal Phase III results for afatinib in first-line treatment of EGFR mutation-positive NSCLC at ASCO 2012
6. New Data to be Presented at the Annual American Thoracic Society International Conference Demonstrates Depth of Boehringer Ingelheim Respiratory Research Pipeline
7. Boehringer Ingelheim Announces Launch of GLORIA™-AF Registry in Newly-Diagnosed Patients with Non-Valvular Atrial Fibrillation
8. Soligenix Announces Issuance of US Patent for Topically Active Steroids to Treat Inflammatory Gastrointestinal Disorders
9. Henry Schein Announces New $500 Million Credit Facility
10. BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
11. Biodel Announces Phase 2 Clinical Trial Initiation Of Ultra-Rapid-Acting Insulin Candidate BIOD-123
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/30/2016)... PUNE, India , May 30, 2016 ... new market research report "Healthcare Biometrics Market ... Behavioral (Signature, Voice)), Multifactor, Multimodal), Application (Workforce ... Global Forecast to 2021", published by MarketsandMarkets, ... 2,848.3 Million by 2021 from USD 1,182.6 ...
(Date:5/30/2016)... May 30, 2016 - DCGI grants limited ... to Buerger,s disease - Stempeucel® becomes 5th off-the-shelf Stem ... the world - Buerger,s Disease (also known as Thromboangiitis ... and Globally - Prevalence of Buerger,s Disease ... and 2 per 10,000 persons in the European Community & ...
(Date:5/27/2016)... 2016 LabStyle Innovations Corp . ... Tool, today announced that the Company,s Chief Financial Officer, ... being held June 1-2 in New York, NY ... 7-9 in Los Angeles, CA. ... and operational milestones, including the U.S. FDA Clearance and commercial ...
Breaking Medicine Technology:
(Date:5/31/2016)... , ... May 31, 2016 ... ... healthcare that considers individuals’ genetic characteristics and the physical and behavioral worlds ... work in sync. In personalized medicine, diagnosing an individual’s disease depends on ...
(Date:5/31/2016)... HOUSTON, TEXAS (PRWEB) , ... May 31, 2016 ... ... is live in Greater Houston Healthconnect’s (Healthconnect) regional health information exchange, which enables ... prior medical records for their patients from other participating organizations in the exchange. ...
(Date:5/31/2016)... ... 31, 2016 , ... CallTrackingMetrics's software gives healthcare ... the performance of sales and support staff, and to efficiently route calls to ... customers to record, transcribe, route, document, and report on everything going on in ...
(Date:5/31/2016)... , ... May 31, 2016 , ... The Global ... today released ten predictions on the future of wellness, travel, spa and beauty in ... travel, spa and beauty companies to leading economists and researchers - to forecast where ...
(Date:5/31/2016)... ... 2016 , ... Interest is on the rise for using the CRISPR-Cas9 system ... for RNAi hit validation. A key reason may be that high-throughput synthesis—combined with a ... RNA (crRNA) collections in arrayed formats. , Arrayed crRNA screens have ...
Breaking Medicine News(10 mins):