Camptosar Approved for First-Line Rx of Advanced Colon Cancer
WASHINGTON-Pharmacia & Upjohn’s Camptosar (irinotecan) has won FDA approval for use as a first-line agent in metastatic colorectal cancer, in combination with 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.
WASHINGTONPharmacia & Upjohns Camptosar (irinotecan) has won FDA approval for use as a first-line agent in metastatic colorectal cancer, in combination with 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).
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![“Everyone—patients, doctors—we all want the same thing. We want [patients] to live longer,” said Kiran Turaga, MD, MPH, on patients with peritoneal surface malignancies.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F9b290688648a249e516474c175a3c06309426d15-2950x1568.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=30 "“Everyone—patients, doctors—we all want the same thing. We want [patients] to live longer,” said Kiran Turaga, MD, MPH, on patients with peritoneal surface malignancies.")
