Iressa (gefitinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

AstraZeneca Pharmaceuticals, LP. Iressa (gefitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf. Revised May 2021. Accessed October 30, 2024.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Gefitinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Gefitinib