U.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC

RIDGEFIELD, Conn., Jan. 15, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for afatinib is currently under review for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation as detected by an FDA-approved test. Under the Prescription Drug User Fee Act (PDUFA), the FDA goal for reviewing a drug with Priority Review status is six months from the NDA filing acceptance date.¹  The FDA target action date for afatinib will be in the third quarter of 2013.  

Recently, afatinib was also granted orphan drug designation – a status given to a product intended for the treatment of a rare disease or condition.² In the United States, orphan drug status provides for seven years of market exclusivity for the orphan drug indication following FDA approval.² Currently there are no therapies specifically approved by the FDA for patients with locally advanced or metastatic NSCLC with an EGFR mutation.

"The NDA filing of afatinib represents Boehringer Ingelheim's commitment to addressing the significant need that exists for patients with EGFR mutation-positive advanced non-small cell lung cancer," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. "We are pleased that the FDA has accepted the afatinib application under Priority Review and look forward to working with the agency in the coming months."

The NDA submission for afatinib is supported by Boehringer Ingelheim's comprehensive LUX-Lung clinical trial program, including LUX-Lung 3, the largest Phase III trial conducted to date in first-line EGFR mutation-positive, locally advanced or metastatic NSCLC patients. 

"This is an exciting milestone for Boehringer Ingelheim, as this marks our first oncology compound to be submitted for FDA review in the United States," said Kevin Lokay, vice president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "Based on the acceptance of the afatinib application, along with our developing oncology pipeline, we are moving forward with our plans to establish a world-class oncology commercial organization."

To facilitate the rapid identification of EGFR mutations, Boehringer Ingelheim is partnering with QIAGEN – a leading global provider of sample and assay technologies – to develop a companion diagnostic for afatinib. 

About Afatinib
Afatinib is an investigational, oral, once-daily irreversible ErbB Family Blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB4.³ It is currently in Phase III clinical development in advanced NSCLC, head and neck and breast cancer.  Afatinib is not approved by the FDA; its safety and efficacy have not been established. 

In Europe, Boehringer Ingelheim announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation-positive NSCLC in September 2012.

About the Companion Diagnostic
Boehringer Ingelheim and QIAGEN are partnering on a companion diagnostic for afatinib. The therascreen^® EGFR RGQ PCR kit is being developed by QIAGEN to identify patients with EGFR mutation-positive tumors.

EGFR is a specific protein found on the surface of cells.  In some people, genetic mutations involving EGFR lead to its constant activation (or over expression), which is associated with uncontrolled cell division and the development of advanced NSCLC. 

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. 

For information about participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com or call 1.866.725.7110. Healthcare providers interested in learning more about Boehringer Ingelheim clinical trials in oncology can 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 has a demonstrated commitment to corporate social responsibility. 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 U.S. Food and Drug Administration. Fast Track, Accelerated Approval and Priority Review. Last accessed December 5, 2012. Available here: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm.
² U.S. Food and Drug Administration. Developing Orphan Products: FDA and Rare Disease Day. Last accessed December 11, 2012. Available here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107293.htm.
³ Solca F et al. Target Binding Properties and Cellular Activity of Afatinib (BIBW 2992), an Irreversible ErbB Family Blocker. Journal of Pharmacology and Experimental Therapeutics. Published August 20, 2012.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.