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Executive Summary

FDA CLEARS TREATMENT IND FOR COLON CANCER DRUG LEVAMISOLE in combination with 5-fluorouracil, the agency announced in a May 8 "Talk Paper." Under the Treatment IND protocol, levamisole, an immunostimulant with known anti-tumor effects in animals, may be used in conjunction with the approved cancer drug 5-flurouracil as an adjuvant treatment beginning seven to 30 days after surgical removal of the cancer. In addition, the National Cancer Institute has designated levamisole a Group C cancer treatment, indicating that the drug has been shown potentially effective and can be administered by properly trained physicians. In February, NCI released the results of preliminary studies conducted at the Mayo Clinic, which demonstrated a 30% improvement in survival rates of patients treated with the levamisole/fluorouracil combination. FDA estimates that more than 25,000 patients would be eligible for treatment each year under the protocol. More than 110,000 new cases of colon cancer will be diagnosed in 1989, while the disease will result in 44,000 deaths during the year, the agency said.

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