The Food and Drug Administration criticized the biotech company’s clinical study for Clolar, stating the company failed to perform a randomized controlled study to support their application of the drug to treat elderly patients. The drug clofarabine is currently approved in treating patients under age 21 for acute lymphoblastic leukemia.

Genzyme that states their drug Clolar should be approved relied on a 116 patient single-arm phase II study of newly diagnosed patients, which had one adverse prognostic factor.

Another biotech new drug application that was scheduled for review today is Onrigin, laromustine the injection drug for treatment of acute myeloid leukemia by Vion Pharmaceuticals (OTC:VION) . This is designed for the treatment to induce remission in patients that are over 60 years of age and will be reviewed September 2, by the Oncologic Drugs Advisory Committee.

The laromustine injection is designed for people over the age of 60 that have one or more factors that are unfavorable to be used as a remission induction therapy. Concerns have been raised about this drug by the FDA, due to the single-arm study data and toxicities when combined with cytarabine.