Tarceva FDA Approval History
Last updated by Judith Stewart, BPharm on March 8, 2021.
FDA Approved: Yes (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 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 the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) and for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
- first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
Development timeline for Tarceva
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