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Treatment for Chronic Lymphocytic Leukemia

Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia

BERKELEY HEIGHTS, N.J., July 27, 2006 -- Genta Incorporated announced that the Company has been notified by the Food and Drug Administration (FDA) that the Oncology Drug Advisory Committee (ODAC) will review the New Drug Application (NDA) for Genasense (oblimersen sodium) Injection plus chemotherapy for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) on September 6, 2006. The NDA has a target action date for a marketing approval decision by October 29, 2006 under the Prescription Drug User Fee Act (PDUFA).

"We are very pleased to have this opportunity to present the Genasense data in CLL to the ODAC," commented Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "This event represents the next key step in the approval process for Genasense, and we look forward to reviewing our application with the FDA advisors."

Posted: July 2006

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