FDA seeks new trial of Genzyme drug

The FDA asked Genzyme to conduct a randomized controlled study, which compares patients taking the drug to those taking alternative treatments. Such studies are commonly used to gauge a drug’s effect. However, Genzyme said doctors were unwilling to put cancer patients on the alternative treatment recommended by the FDA.

Panelists complained that without a comparison it was difficult to say whether patients would truly do better taking Clolar than drugs already in use.

Genzyme researchers said it was too soon to decide whether the company would go back and conduct the recommended trial.

Genzyme vice president Dr. Mark Hayes noted the FDA has pushed back the deadline for making a decision on Clolar - from September to December.

During yesterday’s meeting, Genzyme emphasized positive results from a 112-patient study of its drug. About 46 percent of patients experienced remission of their cancer, and only 10 percent died within a month of the study’s launch. FDA reviewers said it was unclear whether the patients selected by Genzyme were truly too frail to undergo chemotherapy treatment.