Panel: More Data Required to Expand Clolar Use to Elderly

The FDA’s Oncology Drugs Advisory Committee has voted 9–3 to recommend that Genzyme conduct a randomized, controlled trial of its leukemia drug Clolar (clorfarabine) before the agency considers expanding the drug’s indications to include elderly patients. The FDA had emphasized the need for the randomized trial at a pre-sNDA meeting in December 2007, Martin Cohen, medical officer at the FDA’s Division of Drug Oncology Products, said during the agency’s presentation to the panel.
Drug Industry Daily