Chronic Lymphocytic Leukemia

NDA submitted for Genasense in patients with relapsed or refractory CLL

Published in Cancer Weekly, August 2nd, 2005

Genta, Inc., (GNTA) announced that the company has initiated submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) seeking marketing approval of Genasense (oblimersen sodium) Injection, its lead anticancer compound.

The NDA seeks accelerated approval for the use of Genasense in combination with fludarabine plus cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia (CLL) who have previously received fludarabine. Genasense has received fast track designation by the FDA in CLL, meaning the indication represents an unmet medical need. Fast track designation enables the company to submit the NDA on a "rolling"...

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Source: Cancer Weekly (2005-08-02)

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