Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR somatic variants status confers therapeutic sensitivity to Afatinib in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to afatinib for the first-line treatment of patients with metastatic non-small lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.
This statement is based on a regulatory approval from the Food and Drug Administration:
GILOTRIF is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test (1.1) Limitations of Use: Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations.