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FDA approves treatment for advanced colorectal cancer

The US Food and Drug Administration (FDA) has approved Pharmacia and Upjohn's chemotherapy drug Camptosar, for use as a first-line treatment for colorectal cancer that has spread to other body parts.

The drug had previously been approved for use only in patients who failed to respond to other chemotherapy drugs.

According to the FDA, about 130,000 people in the United States will be diagnosed with colorectal cancer this year. In many of these people, maybe up to half, the cancer will spread beyond the colon or the rectum and these people will require treatment with chemotherapy.

Camptosar (irinotecan) is approved for use in conjunction with 5-fluorouracil and leucovorin. The FDA reports that two clinical studies showed that "the combination of Camptosar and 5-fluorouracil plus leucovorin resulted in a significant delay in the time at which tumors progressed and significant improvement in survival compared with 5-fluorouracil and leucovorin alone." The side effects of Camptosar, the FDA notes, include "severe diarrhea (which can be prolonged and require medical treatment), nausea, vomiting and neutropenia (a drop in white blood cells)."

Pharmacia notes that Camptosar in combination with 5-fluorouracil plus leucovorin is currently being studied as a treatment for earlier stage colorectal cancer. The potential for Camptosar to treat other cancers, such as lung and pancreatic cancers, also is being investigated.


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