ImClone’s Gene Test Battle
5/21/2008 Robert Langreth Forbes.com ImClone Systems' breakthrough colon cancer drug Erbitux has become a billion-dollar best seller as a one-size-fits-all drug for patients who have failed treatment with chemotherapy. But emerging new gene findings indicate that the high-priced drug may be useless in nearly half of colon cancer patients--and that a simple gene test could allow doctors to predict in advance which patients are likely to benefit. The drug, co-marketed by ImClone and Bristol-Myers Squibb, costs $38,000 for a four-month course of treatment. The result is one of the first examples of personalized medicine in colon cancer. It helps explain why tumors shrink dramatically in a minority of patients who get the drug while most others get little benefit. The new gene test could allow doctors to give the drug only to patients who are likely to benefit, and avoid those who are likely to just get side effects. Side effects of the drug include skin rashes and infections in the fingers and toes. A series of studies published over the last several months indicate that about 35% to as much as 45% of colon patients probably should not be taking Erbitux or a similar drug from Amgen called Vectibix. These patients have tumors with a mutation in a growth-promoting gene called kras that may render the drugs ineffective. Erbitux and Vectibix are antibodies that bind to receptors on the cell surface called EGF and blocks signals that turn kras on. But the mutations apparently cause kras to become permanently [...]