FDA: Problems with Genzyme study of leukemia drug

By Associated Press

Story

Summary

Federal regulators are questioning whether Genzyme's leukemia drug should be approved for older patients based on limited studies conducted by the biotech drugmaker.

Story Published: Aug 28, 2009 at 8:38 AM PST

Story Updated: Aug 28, 2009 at 8:38 AM PST

WASHINGTON (AP) - Federal regulators are questioning whether Genzyme's leukemia drug should be approved for older patients based on limited studies conducted by the biotech drugmaker.

Cambridge, Mass.-based Genzyme has asked the Food and Drug Administration to approve its drug Clolar for adults older than 60, who have leukemia but are not healthy enough to undergo chemotherapy. Leukemia is a cancer of the blood.

In documents posted online, FDA reviewers complain about several problems with the company's study. Primarily, the 112-patient study did not compare patients taking the drug to those taking a sham treatment, a practice commonly used to gauge a drug's effect.

The FDA will ask a panel of cancer experts to weigh in on the drug next week.