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Imclone Tumor Reducing Drug Approved

Melissa Gordon | October 20 2004

Imclone's new cancer drug Erbitux has been approved by the Food and Drug Administration. The drug is genetically targeted at tumors with the protein HER-1, a protein commonly associated with colorectal tumor growth; on the contrary, it's also a major component in keeping the colon and rectum lining healthy. It doesn't make people live longer so far as they can tell, but it shrinks tumors so that they cause less problems with other body functions; therefore the drug is usually only used in patients who've failed to go into remission with other therapies and whose cancer has spread throughout their body. This 'targeted' therapy is pretty disappointing; after all there are other known similarities in tumors genetically that could be targeted with a better effect.

The FDA originally felt that Erbitux studies didn't have complete enough information about its safety and were reticent to approve it. I always find it odd when the FDA doesn't approve a drug, since so many bad drugs have been approved and most medicines have never even had a clinical trial done on woman but are approved for female usage.

According to the FDA Erbitux can cause side effects such as low blood pressure, difficulty breathing, interstitial lung disease (often irreversible scarring and hardening of the lungs), acne like rash, dry skin, tiredness, weakness, fever, constipation and abdominal pain.

References & Resources:
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Thursday, March 11, 2004

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