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.

About GILOTRIF

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

Diarrhea

•Diarrhea has resulted in dehydration with or without renal impairment; some of these cases were fatal. In the pivotal study, diarrhea occurred in 96% of patients treated with GILOTRIF (n=229), of which 15% was Grade 3 in severity and occurred within the first 6 weeks. Renal impairment as a consequence of diarrhea occurred in 6.1% of patients treated with GILOTRIF, out of which 3 (1.3%) were Grade 3.
•For patients who develop prolonged Grade 2 diarrhea lasting more than 48 hours or greater than or equal to Grade 3 diarrhea, withhold GILOTRIF until diarrhea resolves to Grade 1 or less, and resume GILOTRIF with appropriate dose reduction. 
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