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Kate O’Connor
Boehringer Ingelheim Pharmaceuticals Inc.
Public Relations
Phone: 203-791-6250
Email: usnews@boehringer-ingelheim.com

FDA approves GILOTRIF™ (afatinib) as first-line treatment for metastatic non-small cell lung cancer with common EGFR mutations

Approval supported by one of the largest Phase III trials in patients with EGFR mutation-positive advanced NSCLC

Ridgefield, CT, July 12, 2013 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved GILOTRIF™ (afatinib) tablets for oral use, as a new first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.1 Discovered and developed by Boehringer Ingelheim, GILOTRIF is the first FDA-approved oncology product from the company.

In some people, genetic mutations lead to the constant activation of the EGFR protein, which is associated with uncontrolled cell division and the development and progression of NSCLC.2 Among patients diagnosed with NSCLC (the most common form of lung cancer3), it is estimated that between 10 and 15 percent of Caucasians and approximately 40 percent of Asians have EGFR mutations4 – which in 90 percent of cases are one of the two most common EGFR mutations (Del19 or L858R).5

“The approval of GILOTRIF offers a new treatment option and provides a personalized treatment approach for patients with EGFR mutation-positive metastatic non-small cell lung cancer,” said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology. “Over the past decade, great progress has been made in understanding the biology of lung cancer and GILOTRIF is an example of how, at BI, we are translating this knowledge into a new treatment option for patients.”

To determine if a patient is eligible for GILOTRIF, physicians must conduct a test for genetic mutations – also known as biomarker testing – to determine if a common EGFR mutation is present. For this reason, and in line with FDA’s current guidance, BI collaborated with QIAGEN, a leading global provider of sample and assay technologies, on the development of a companion diagnostic for GILOTRIF. QIAGEN’s therascreen® EGFR RGQ PCR Kit was reviewed and approved by the FDA in parallel to GILOTRIF and will be used to identify patients who may be eligible for treatment.

“We are truly excited to be able to offer GILOTRIF as a new treatment option for these patients. This approval is an achievement for Boehringer Ingelheim Oncology and the many teams and individuals who committed themselves to developing this therapy based on its potential identified in the clinical trial program,” said Kevin Lokay, vice president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “GILOTRIF marks the first, of what we expect will be many, oncology products to emerge from our research and development program.”

For more information about the FDA-approved therascreen® EGFR RGQ PCR Kit, please contact QIAGEN at +49 2103 29 11826.

About the LUX-Lung 3 Clinical Trial
The approval of GILOTRIF was supported in part by the LUX-Lung 3 trial – one of the largest Phase III trials conducted to date in the first-line EGFR mutation-positive, locally advanced or metastatic NSCLC treatment setting.

Results showed that within the general study population, in the GILOTRIF arm, median progression-free survival (PFS) was 11.1 months versus 6.9 months for the chemotherapy arm (pemetrexed/cisplatin) (p<0.001).1 Approximately 90 percent of patients in the study had the most common EGFR mutations (Del19 and L858R).1 In these patients, the median PFS in the GILOTRIF arm was 13.6 months versus 6.9 months in the chemotherapy arm.1

In the LUX-Lung 3 trial, the most common drug-related adverse events (AEs) observed with GILOTRIF were diarrhea (96%), rash/dermatitis acneiform (90%), stomatitis (71%), paronychia (58%), dry skin (31%), decreased appetite (29%) and pruritus (21%).1 Serious adverse events (SAEs) were reported in 29 percent of patients treated with GILOTRIF; the most frequent SAEs were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each).1

About GILOTRIF (afatinib)
GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.1

Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.1

GILOTRIF is an oral, once-daily kinase inhibitor that is designed to bind and irreversibly inhibit the following receptors: EGFR (ErbB1), HER2 (ErbB2) and ErbB4.1

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Diarrhea

Bullous and Exfoliative Skin Disorders

Interstitial Lung Disease (ILD)

Hepatic Toxicity

Keratitis

Embryofetal Toxicity

ADVERSE REACTIONS

DRUG INTERACTIONS
Effect of P-glycoprotein (P-gp) Inhibitors and Inducers

USE IN SPECIFIC POPULATIONS
Nursing Mothers

Renal Impairment

Hepatic Impairment

Full GILOTRIF prescribing information is available here or by contacting Boehringer Ingelheim’s Medical and Technical Information (MTI) Unit at 1-800-542-6257.

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 discover and 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. The company is also evaluating a robust and growing pipeline of early-stage oncology compounds in areas including growth/survival signaling, immunotherapy and epigenetics.

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 140 affiliates and more than 46,000 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.

Social responsibility is a central element of Boehringer Ingelheim’s culture. 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.

In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.us.boehringer-ingelheim.com.

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References
1GILOTRIF Prescribing Information.
2Woodburn J. R. The epidermal growth factor receptor and its inhibition in cancer therapy. Pharmacol. Ther 1999; 82: 241-250.
3American Cancer Society. Cancer Facts and Figures: 2012. Available at: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf. Last accessed April 27, 2012.
4Quest Diagnostics. Lung Cancer Mutation Panel (EGFR, KRAS, ALK). Available at: http://questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=Lung/TS_LungCancerMutation_Panel.htm Last accessed May 18, 2012.
5Yu, J. et al. “Mutation-specific antibodies for the detection of EGFR mutations in non-small-cell lung cancer.” Clinical Cancer Research; May 1, 2009. Available at: http://clincancerres.aacrjournals.org/content/15/9/3023.long. Accessed May 8, 2012.


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