FDA knocks back B-MS cancer drug UFT

The US Food and Drug Administration has decided that Bristol-MyersSquibb's New Drug Application for its UFT (tegafur/uracil) capsules plus leucovorin calcium tablets as a treatment for advanced colorectal cancer is not approvable in its current form. If registered, the drug combination would be the first oral alternative to intravenous chemotherapy to become available in the USA for colorectal cancer.

The company said it was disappointed with the decision, particularly in light of the fact that the NDA was reviewed by the FDA's Oncologic Drugs Advisory Committee in September 1999, at which point the ODAC voted unanimously that the UFT/leucovorin regimen provided survival at least as good as the standard intravenous comparator regimen based on 5-fluorouracil (Marketletter September 27, 1999).

Last March, after discussions with the agency, the company decided to withdraw and refile its NDA for UFT to allow additional review time for new analyses of its existing dataset for the drug, but "the FDA has now decided that the NDA submission did not meet its standards for approval," according to B-MS.