Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Erlotinib in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to erlotinib for the 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, receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Erlotnib's product label further states that safety and efficacy of erlotnib have not been established in patients with NSCLC whose tumors have other EGFR mutations. Furthermore, the product label states that it is not recommended for use in combination with platinum-based chemotherapy.
This statement is based on a regulatory approval from the Food and Drug Administration:
TARCEVA is a kinase inhibitor indicated for the 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations. TARCEVA is not recommended for use in combination with platinum-based chemotherapy.