Therapeutic Response

EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Gefitinib in patients with Non-Small Cell Lung Cancer.

Statements

Source and description

Iressa (gefitinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to gefitinib 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. Gefitinib's package insert includes the following limitation of use: safety and efficacy of gefitinib have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.