Iressa (gefitinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

AstraZeneca Pharmaceuticals, LP. Iressa (gefitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206995s000lbl.pdf. Revised July 2015. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

IRESSA is a tyrosine kinase inhibitor 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 IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Gefitinib
FDA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Gefitinib