Genta's Genasense to be reviewed by FDA's Oncology Drug Advisory Committee

By Elaine Rigoli

Tampa, Fla., July 27 - Genta, Inc. has been notified by the Food and Drug Administration that the Oncology Drug Advisory Committee (ODAC) will review the New Drug Application for Genasense (oblimersen sodium) Injection plus chemotherapy for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) on Sept. 6.

The NDA has a target action date for a marketing approval decision by Oct. 29 under the Prescription Drug User Fee Act.

"We are very pleased to have this opportunity to present the Genasense data in CLL to the ODAC. 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," chief executive officer Raymond P. Warrell Jr. said in a news release.

Genta is a biopharmaceutical company based in Berkeley Heights, N.J.

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