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
Date | Article |
---|
Jul 6, 2012 | Approval 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, 2011 | Approval FDA 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 | Approval FDA Approves Erbitux (cetuximab) to Treat Irinotecan Refractory or Intolerant Metastatic Colorectal Cancer |
Further information
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