Cetuximab

Cetuximab (marketed under the name Erbitux) is a chimeric Merck KGaA.

Cetuximab faces stiff competition^{[citation needed]} from Amgen approved by the FDA in November 2006. One of the main differences is that Cetuximab is an IgG1 antibody, and Panitumumab an IgG2 one. Their properties are not absolutely identical[1]. Cetuximab costs $30,000 for eight weeks of treatment per patient.^[1]

Mode of action

Cetuximab is believed to operate by binding to the extracellular domain of the EGFR of all cells that express EGFR, which includes the subset "cancer cells", preventing ligand binding and activation of the receptor. This blocks the downstream signaling of EGFR resulting in impaired cell growth and proliferation. Cetuximab has also been shown to mediate antibody dependent cellular cytotoxicity (ADCC).

Clinical uses

Colorectal Cancer

Cetuximab is used in metastatic colon cancer and is given concurrently with the chemotherapy drug DNA topoisomerase I, resulting in fatal damage to the DNA of affected cells. While there remains some scientific controversy on this, assessment for EGFR expression is required for use in Colorectal Cancer, but not in Head & Neck Cancer. It is best to refer to updated Prescription Information [2].

Head and neck cancer

Cetuximab was approved by the radiation therapy for treating squamous cell carcinoma of the head and neck (SCCHN) or as a single agent in patients who have had prior platinum-based therapy.

One of the side effects of Cetuximab therapy is the incidence of, possibly severe, acne-like rash.

ImClone insider trading scandal

Further information: ImClone Systems#Insider trading scandal

The initial failure of FDA announced its refusal to approve the drug for public use. Martha Stewart, Samuel D. Waksal (the founder and former CEO of ImClone), and their broker were indicted, and Stewart and Waksal were sentenced to prison. ImClone shares dropped sharply in the aftermath of the insider trading scandal.

A new clinical trial and FDA approval of the drug in 2004 for use in colon cancer.

References

1. ^ Schrag, D (Jul 2004). "The price tag on progress – chemotherapy for colorectal cancer". New England Journal of Medicine 351 (4): 317-319.