According to a report by BioSpace, the US Food and Drug Administration (FDA) has requested further data from Genta for the approval of oblimersen sodium (Genasense) injection for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL).
The Centre for Drug Evaluation and Research (CDER) of the FDA has suggested that further efficacy data are required, which can be by conducting another trial, or collection of additional information on disease progression, from a previous trial.
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03-18-2008, 07:11 PM
US FDA requests further data for consideration of approval o
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