Erbitux FDA Approval History

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

Erbitux is epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of colorectal cancer and Head and Neck Cancer.

Development Timeline for Erbitux

Date	Article
Nov 7, 2011	ApprovalFDA Approves Erbitux to Treat Late-stage Head and Neck Cancer
Dec 8, 2008	Erbitux Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted to U.S. Food and Drug Administration
Oct 31, 2008	Erbitux 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, 2008	ImClone Submits Supplemental Biologics License Application for Erbitux in First-Line Head and Neck Cancer
Sep 4, 2007	Merck Applies to Extend Use of Erbitux for 1st-Line Colorectal Cancer
Jun 11, 2007	FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer
Aug 30, 2005	ImClone Systems Incorporated and Bristol-Myers Squibb File Supplemental Biologics License Application for Erbitux for Treatment of Head and Neck Cancer
Feb 12, 2004	ApprovalErbitux ImClone - Treatment for Advanced Colorectal Cancer

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