Regulatory approval

Published by the Food and Drug Administration. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	EGFR Somatic variants	Non-Small Cell Lung Cancer	Afatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-01-12	Food and Drug Administration	Indication received traditional approval.