Cetuximab

Cetuximab (Erbitux®) is a chimeric monoclonal antibody given by intravenous injection for treatment of colorectal cancer.

Mode of action

Erbitux is believed to operate by locking onto the epidermal growth factor receptors of cancer cells. This prevents normal epidermal growth factors from stimulating cell growth.

Erbitux is usually given concurrently with irinotecan (Camptosar®) a form of chemotherapy that blocks the effect of DNA ligase, resulting in fatal damage to the DNA of affected cells.

There is also a medical laboratory test that determines the probability of success with Erbitux therapy.

ImClone insider trading scandal

The failure of ImClone Systems to prepare an acceptable filing for FDA led to the infamous Martha Stewart insider trading scandal when ImClone's CEO sold his daughter's ImClone shares and this information was leaked to Martha before the FDA announced its refusal to approve the drug for public use. Martha Stewart, the founder and former CEO of ImClone Samuel D. Waksal and their broker were indicted, and Martha and Sam were sentenced to jail. ImClone shares dropped sharply in the aftermath of the insider trading scandal.

A new clinical trial and FDA filing prepared by Imclone's partner Merck KGaA ("German Merck," not to be confused with the similar US company), resulted in an FDA approval of the drug in 2004.

Although the stock price recovered dramatically after success in the second clinical trial, ImClone shares have suffered recently due to disappointing sales and slow adoption rate of its only marketable product – Erbitux.

Erbitux is widely considered to be a very good drug, perhaps even a wonderdrug. Unfortunately, ImClone Systems is widely seen as a corporate parent incapable of bringing Erbitux to widespread use across several indications in a timely and efficent manner.

Erbitux is distributed inside the United States by ImClone Systems and Bristol-Myers Squibb, while it is distributed outside North America by Merck KGaA. It faces stiff competition from Avastin Genentech and potential competition from a new drug currently under development by Abgenix.

External links

• FDA Erbitux (cetuximab) Information Page
• Erbitux site from Bristol-Myers Squibb, ImClone Systems, and Merck KGaA