Americans will soon have access to Gilotrif (afatinib) tablets, a new first-line 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, according to manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. The safety and efficacy of Gilotrif have not been established in patients whose tumors have other EGFR mutations, according to the company.

“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, MD, vice president, Clinical Development and Medical Affairs, Oncology in response to the FDA approval. “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.”

Physicians must conduct biomarker testing to determine if a common EGFR mutation is present in order for a patient to be eligible for the drug. For this reason, Qiagen’s therascreen EGFR RGQ PCR Kit was reviewed and approved by the FDA in parallel to Gilotrif and will be used to determine a patient’s eligibility for treatment.