Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

Citation

OSI Pharmaceuticals, LLC. Tarceva (erlotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf. Revised October 2016. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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