Good Drug, Bad Luck: Business, Regulatory Issues Can Create Obstacles for Drug Development

Extract

Anybody involved with cancer knows that bad things happen to good people. Sometimes bad things happen to good cancer drugs, too, for reasons ranging from regulatory red tape to intellectual property constraints. The stories of two drugs—one an oral chemotherapy, the other a bone-seeking radiopharmaceutical—show how regulatory or licensing barriers can block a promising compound's path.

UFT: When One Plus One Equals Zero

At the annual meeting of the American Society for Clinical Oncology (ASCO) in June 2004, Norman Wolmark, M.D., had good news: results from a large trial of several years' duration, in which an oral chemotherapy drug called UFT (uracil/tegafur) was tested in some 1,600 patients with colorectal cancer whose primary tumors had been removed. Wolmark, chairman of the Department of Human Oncology Allegheny General Hospital in Pittsburgh and the study's lead investigator, reported that an oral regimen of UFT plus another drug, leucovorin, was as effective as the existing standard treatment—intravenous 5-fluorouracil plus leucovorin (5-FU/LV)—when the trials were begun in 1997. The two regimens were about equally toxic.