[MOL] Colorectal cancer treatment approved.... [02265] Medicine On Line

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[MOL] Colorectal cancer treatment approved....

FDA OKs Colorectal Cancer Treatment

April 20, 2000

WASHINGTON (AP) - For the first time in years, the government has approved a new first-line treatment for patients whose colorectal cancer has spread, saying the newer therapy could prolong survival.

      The Pharmacia Corp.'s Camptosar won Food and Drug Administration approval Thursday. It can be used, in combination with two standard cancer drugs, as soon as colorectal cancer has metastasized.

      Camptosar has been sold as a follow-up cancer treatment since 1996.

      The new approval ``will likely change the way patients with metastatic colorectal cancer are treated,'' said Dr. Robert Justice, FDA's deputy director of cancer drugs.

      About 130,000 Americans will be diagnosed with colorectal cancer this year. About half of the patients treated with surgery, sometimes followed with chemotherapy or radiation, will have their cancer spread beyond the colon or rectum.

      The new approval comes after two clinical trials studied whether infusing patients with Camptosar in addition to standard treatment - the older drugs 5FU and leucovorin - helped newly metastatic patients. Those studies found median survival prolonged by about three months with the newer combination.

      Side effects of Camptosar include severe diarrhea that may require medical treatment, as well as nausea, vomiting and a drop in white blood cells.

      Pharmacia said it expects a 60 percent increase in patients using Camptosar as a result of the new FDA approval. A course of treatment, lasting up to six months, costs about $15,000.


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