Federal regulators, set to hear from a panel of cancer experts on Genzyme's leukemia drug Clolar on Tuesday, indicated that the drugmaker's clinical data may not be sufficient. Clolar is approved to treat children, but Genzyme is seeking the agency's permission to market Clolar to adults aged 60 and older who suffer from acute myeloid leukemia (AML) but cannot withstand chemotherapy.
The FDA staffers' primary concern stems from the fact that the developer's 112-patient study did not compare Clolar with a placebo. "The lack of a randomized study combined with the heterogeneous patient population regarding AML prognostic factors makes interpretation of the study results difficult," FDA staff wrote in a preliminary review released today.
- here's the story from Reuters