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Last Updated: 06/21/23

Success Story

Erbitux (NSC 632307)

“Erbitux, a targeted therapy for colon cancer, might be forever known as the drug that led to Martha Stewart’s downfall.”2 Martha Stewart’s sale of her ImClone stock around the time ImClone’s application for FDA approval of Erbitux was stalled created a scandal and led to her imprisonment.

Erbitux is the only FDA-approved recombinant, chimeric monoclonal antibody against the cellular domain of human EGFR. Although treatment with Erbitux has not been shown to extend patients’ lives, it has been shown to shrink tumors and delay tumor growth, especially when it is used in combination with irinotecan.2 When combined with irinotecan, Erbitux yields a 23% response rate, with median response duration of 5.7 months. Two studies are under way to examine the ability of Erbitux to stop the progression of colorectal cancer and to increase survival time.3


Erbitux (NSC 632307), known generically as cetuximab, is one of four NCDDG-developed agents approved by the FDA since the inception of the NCDDG. This agent, a chimera comprising human and mouse monoclonal antibodies against the epidermal growth factor receptor (EGFR), is based on Dr. John Mendelson’s 1980s hypothesis that monoclonal antibodies against EGFR could block receptor activation,1 which in turn would interfere with the cell signaling that leads to increased cell proliferation, angiogenesis, invasion, and metastasis.


In 1990, the NCDDG began work on Erbitux, and in 1999, ImClone Systems of New York commenced phase III trials in collaboration with Merck KGaA of Darmstadt, Germany. In 2001, Bristol-Meyers Squibb and ImClone agreed to co-develop this agent, and the first application for FDA approval was submitted in November of that year.


ImClone submitted its original request for FDA approval in 2001, but the FDA determined that this application could not be reviewed because of missing information.3 However, in August 2003, ImClone submitted the results of a “large, well-run trial,” the results of the two earlier studies, and the missing information requested by the FDA, and Erbitux received approval for the treatment of metastatic colorectal cancer in 2004. Combinations of Erbitux and radiation or platinum-based chemotherapeutic agents are under exploration.1

1 Developmental Therapeutics Program. Grants and Contracts Operations Branch (GCOB) Website.

2 Bazell R. Strange medicine: Why are the new cancer drugs so expensive? Slate June 23, 2004.

3 U.S. Food and Drug Administration. FDA approves Erbitux for colorectal cancer. FDA News 2004.


DTP NCDDG poster (pdf)