Gilotrif™ (afatinib) tablets will be available in the U.S. the week of September 2
Boehringer Ingelheim Pharmaceuticals, Inc. has announced that Gilotrif™ (afatinib) tablets for oral use will be commercially available in the U.S. the week of September 2.
The U.S. Food and Drug Administration (FDA) approved GILOTRIF on July 12, 2013 as a new first-line -- or 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. Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.
Supporting Patient Access to GILOTRIF
Boehringer Ingelheim has established a comprehensive patient support program that will provide a broad range of access and clinical support solutions, including financial support services. One of the goals of this program, called Solutions Plus™, is to help patients who are prescribed GILOTRIF gain access to the medicine quickly and affordably. More information can be provided by calling a Solutions Plus™ Patient Care Advocate at 1-877-814-3915 or by visiting www.bisolutionsplus.com.
Until GILOTRIF becomes commercially available, eligible patients in need of afatinib may be enrolled in the Expanded Access Program (EAP); at the time of availability, Boehringer Ingelheim will provide support to healthcare professionals and patients to ensure a smooth transition. Healthcare professionals and patients can learn more about the EAP by calling 1-855-EAP-BIPI (855-327-2474) or by visiting clinicaltrials.gov.
About metastatic NSCLC and EGFR Mutations
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. Among patients diagnosed with NSCLC (the most common form of lung cancer), it is estimated that between 10 and 15 percent of Caucasians and approximately 40 percent of Asians have EGFR mutations -- which in 90 percent of cases are one of the two most common EGFR mutations (Del19 or L858R).
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, Boehringer Ingelheim 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. For more information about the FDA-approved therascreen® EGFR RGQ PCR Kit, please contact QIAGEN at 1-240-686-7425.
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.
Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.
GILOTRIF is an oral, once-daily kinase inhibitor that is designed to irreversibly bind and inhibit the following receptors: EGFR (ErbB1), HER2 (ErbB2) and ErbB4.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Bullous and Exfoliative Skin Disorders
Interstitial Lung Disease (ILD)
Effect of P-glycoprotein (P-gp) Inhibitors and Inducers
USE IN SPECIFIC POPULATIONS
For full GILOTRIF prescribing information, including Patient Information, please visit www.gilotrif.com or contact 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.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.