FDA Appro For Pharmacia & Upjohn's Camptosar

23 June 1996

Within 28 hours of an Oncologic Drugs Advisory Committee recommendation, the US Food and Drug Adminstration approved Pharmacia & Upjohn's anticancer drug Camptosar (irinotecan HCl) Injection for the treatment of metastatic cancer of the colon or rectum that has recurred or progressed after standard therapy with the anticancer agent 5-fluorouracil. Camptosar was processed under the FDA's accelerated approval system, and is said to be the first new colorectal cancer drug in 40 years.

Irinotecan, an original product of Japanese drugmaker Yakult Honsha, is also being developed under European marketing rights by Rhone-Poulenc Rorer (Marketletters passim).

Colorectal cancer is the third-leading cancer killer of men and is diagnosed in about 133,500 people in the USA each year. The standard drug for this condition is 5-FU; around 20% of people given this respond favorably, but in all of these cases the cancer eventually will progress, P&U notes. When that happens, says Dan Von Hoff, director of the Institute for Drug Development and clinical professor of medicine at the University of Texas Health Science Center, "we have no effective medical option, which is why Camptosar is so important." Dr Von Hoff is an investigator in the Camptosar studies. He said the most consistent responses with Camptosar were observed in patients beginning treatment at the recommended 125mg/m2 starting dose. Of 193 patients treated at this dose level, 29 experienced a positive response for an overall response rate of 15%, a good response rate for second-line therapy.

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