Pharmacia Camptosar

Executive Summary

Supplemental indication approved April 20 for irinotecan as first-line treatment for metastatic colorectal cancer in combination with 5-fluorouracil/leucovorin. An FDA "Talk Paper" says the approval was based on studies in which "the combination of Camptosar and 5FU/LV resulted in a significant delay in the time at which tumors progressed and significant improvement in survival compared with 5-FU/LV alone." FDA's Oncologic Drugs Advisory Committee unanimously recommended approval of the combination therapy for the new indication at its March 16 meeting (1"The Pink Sheet" March 20, p. 6)