WASHINGTONPharmacia & Upjohns Camptosar (irinotecan) has won FDA approval for use as a first-line agent in metastatic colorectal cancer, in combination with fluorouracil(Drug information on fluorouracil) (5-FU) and leucovorin. [See ONI April 2000, page 3 for the ODAC review.] The agent was approved as a follow-up colorectal cancer treatment in 1996.
The new approval is based on two clinical trials showing that Camptosar in addition to standard treatment increased median survival by about 3 months. In one phase III study of 385 previously untreated patients, median survival was 17.4 months with Camptosar vs 14.1 for those randomized to 5-FU/leucovorin alone (P = .031) (Lancet, March 25, 2000).