Genta's Genasense rejected by FDA panel

By Elaine Rigoli

Tampa, Fla., Sept. 6 - Genta, Inc. said Wednesday that a majority of members on the Food and Drug Administration's Oncologic Drugs Advisory Committee voted not to recommend approval of Genasense (oblimersen sodium) injection for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia.

While the committee's recommendation is not binding, the FDA will consider this opinion during completion of its ongoing review of the Berkeley Heights, N.J.-based biopharmaceutical company's New Drug Application, targeted for Oct. 29.

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