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Erbitux FDA Approval History

FDA Approved: Yes (First approved February 12, 2004)
Brand name: Erbitux
Generic name: cetuximab
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Colorectal Cancer, Head and Neck Cancer

Erbitux is epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of:
  • Head and Neck Cancer
    • Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.
    • Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinumbased therapy with fluorouracil.
    • Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.
  • Colorectal Cancer
    K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test
    • in combination with FOLFIRI for first-line treatment,
    • in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
    • as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Development Timeline for Erbitux

DateArticle
Jul  6, 2012Approval  FDA Approves Erbitux (cetuximab) as First-Line Treatment in KRAS Mutation-Negative (Wild-Type) Epidermal Growth Factor Receptor (EGFR)-Expressing Metastatic Colorectal Cancer in Combination with FOLFIRI (Irinotecan, 5-Fluorouracil, Leucovorin)
Nov  7, 2011Approval  FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer
Dec  8, 2008Erbitux Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted to U.S. Food and Drug Administration
Oct 31, 2008Erbitux Supplemental Biologics License Application for First-Line Recurrent or Metastatic Head and Neck Cancer Accepted for Priority Review by U.S. Food and Drug Administration
Sep  3, 2008ImClone Submits Supplemental Biologics License Application for Erbitux in First-Line Head and Neck Cancer
Sep  4, 2007Merck Applies to Extend Use of Erbitux for 1st-Line Colorectal Cancer
Jun 11, 2007FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer
Aug 30, 2005ImClone Systems Incorporated and Bristol-Myers Squibb File Supplemental Biologics License Application for Erbitux for Treatment of Head and Neck Cancer
Feb 12, 2004Approval  FDA Approves Erbitux (cetuximab) to Treat Irinotecan Refractory or Intolerant Metastatic Colorectal Cancer

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.