Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

Citation

Boehringer Ingelheim Pharmaceuticals, Inc. Gilotrif (afatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201292s017lbl.pdf. Revised April 2022. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR somatic variants	Non-Small Cell Lung Cancer	Afatinib