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Sep 8
FDA Advisory Committee Gives Negative Review on Genta Incorporated's Genasense® for Treatment of Chronic Lymphocytic Leukemia
The US Food and Drug Administration's (USFDA) Oncologic Drugs Advisory Committee (ODAC) voted not to recommend approval of Genta Inc.'s Genasense® (oblimersen sodium) Injection for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
"While we are disappointed with today's outcome, we strongly believe in the potential of Genasense and what it may offer patients with advanced cancer," said Dr. Raymond P. Warrell Jr., Genta's Chief Executive Officer. "We remain committed to the development of this agent and will continue working with FDA regarding their review of this application."

The committee's recommendation is not binding, but will be considered as a part of the ongoing FDA review of the Genasense New Drug Application (NDA), which is targeted to be completed by October 29, 2006.

Source: Genta Incorporated

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