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Executive Summary

Janssen's Ergamisol (levamisole) was approved for use in combination with 5-fluorouracil (5-FU) as an adjuvant treatment to surgery on June 20 after a seven-and-a-half month review by FDA. J&J's Janssen subsidiary, which will market the product, filed the NDA on Oct. 31 of last year. FDA's Oncologic Drugs Advisory Committee unanimously recommended approval of the treatment regimen in early February. FDA gave levamisole a 1-A rating -- a new chemical entity representing a significant therapeutic advance. Janssen's Ergamisol launch is already underway -- the company is taking orders and will commence shipments to the trade the week of June 25. Janssen estimated the one-year cost of the drug to patients at approximately $1,000-$1,200. Initially used as a veterinary anthelmintic, levamisole has been available for the treatment of colon cancer with 5-FU under a Treatment IND/Group C approval since May 1989. FDA, in a June 20 press release, reported that "more than 4,000 patients" with Dukes' C Colon cancer have received the combination treatment under the Treatment IND. The levamisole/5-FU approval is for colon cancer patients who, despite undergoing surgery, have had their cancer spread to nearby lymph nodes. FDA estimated that the indication covers 21,000 of the 110,000 colon cancer patients in the U.S. Only about 40% of Dukes' C colon cancer can expect to survive five years after surgery. The approved labeling calls for a treatment regimen of 50 mg Ergamisol tablet every eight hours for three days with a concommitant five-day course of I.V. fluorouracil 450 mg/m/day. The 5-FU treatment continues once-a-week beginning 28 days after the five-day course. FDA Oncology & Pulmonary Drug Division Director Greg Burke, MD, called the combination therapy "a promising advance in the treatment of certain patients with colon cancer." NCI Cancer Therapy Evaluation Program Associate Director Michael Freidman, MD, characterized the approval as "an important advance" but noted that "continued clinical trials are absolutely necessary to build on this advance and to further improve treatment." Friedman said that only about one-third of all Dukes 'C patients are receiving the levamisole/5-FU treatment. A National Institutes of Health consensus conference in April recommended that levamisole/5-FU treatment be given to all Dukes' C colon cancer patients post-operatively, including patients in clinical trials. The NIH consensus conference recommendation and the FDA approval are based on two clinical studies sponsored by the National Cancer Institute. A 408-patient study published last year reported a 27% improvement in survival after five years in the levamisole/5-FU group compared to patients just receiving surgery. Another 1,300 patient trial conducted by NCI, called the Intergroup study, confirmed the results of the earlier trial -- 71% of the treatment group were alive three years after surgery versus 51% in the control group. Additional clinical studies with the levamisole/5-FU combination are currently underway for use in treating rectal cancer and and Dukes' B stage colon cancer. * A cost-effectiveness study conducted by NCI on the use of levamisole/5-FU as adjuvant therapy for Dukes' C Colon cancer estimated the cost-savings to society from treating the entire eligible population at $226 mil. The study, conducted by NCI's Martin Brown, factored the$10.8 mil. cost of developing the therapy into an equation that included an estimated one-year cost per patient of $4,220 for the combination drug treatment regimen and another $555 a year for lost work time. Brown noted that the "total budgetary cost of treating all potentially eligible patients with the levamisole/5-FU treatment in 1990 would be approximately $94 mil. with a gain of approximately 53,000 life-years."

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