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Panel: More Data Required to Expand Clolar Use to Elderly

September 2, 2009

Panel: More Data Required to Expand Clolar Use to Elderly
The FDA’s Oncology Drugs Advisory Committee has voted 9–3 to attract favor to that Genzyme conduct a randomized, controlled trial of its leukemia drug Clolar (clorfarabine) face to face with the agency considers expanding the physic’s indications to include elderly patients. The FDA had emphasized the need for the randomized touchstone at a pre-sNDA meeting in December 2007, Martin Cohen, therapeutic magistrate at the FDA’s Division of Drug Oncology Products, said during the agency’s presentation to the panel.

Written by Samanta · Filed Under FDA News