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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

DateArticle
May 15, 2013Approval  FDA Approves Tarceva (Erlotinib) Tablets and Cobas EGFR Mutation Test for Specific Type of Lung Cancer
Apr 18, 2010Approval  FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer
Nov  2, 2005Approval  FDA Approves Tarceva in Combination with Gemcitabine Chemotherapy for Treatment of Locally Advanced, Inoperable or Metastatic Pancreatic Cancer
Nov 18, 2004Approval  FDA Approves Tarceva (erlotinib) for Non-Small Cell Lung Cancer (NSCLC)
Sep 30, 2004OSI Pharmaceuticals Announces Acceptance of Tarceva New Drug Application for Review by the U.S. Food and Drug Administration
Aug  2, 2004OSI Pharmaceuticals and Genentech Announce Completion of New Drug Application for FDA Approval of Tarceva
Jun 29, 2004OSI Pharmaceuticals Announces That Tarceva Has Been Accepted into the FDA's Pilot 1 Program

Further information

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