Regulatory approval
Published by the Food and Drug Administration. Approved
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.
This is written in the approval document.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| 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 |