Tarceva FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 7, 2023.
FDA Approved: Yes (Discontinued) (First approved November 18, 2004)
Brand name: Tarceva
Generic name: erlotinib
Dosage form: Tablets
Company: Genentech, Inc.
Treatment for: Non Small Cell Lung Cancer, Pancreatic Cancer
Tarceva (erlotinib) is a kinase inhibitor for the treatment of certain types of non-small cell lung cancer, and pancreatic cancer.
- Tarceva is 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.
first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
Development timeline for Tarceva
Further information
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