Genta's NDA for Genasense leukemia treatment accepted for FDA review

By Elaine Rigoli

Tampa, Fla., March 1 - Genta, Inc. announced Wednesday that the Food and Drug Administration has accepted the company's New Drug Application for Genasense (oblimersen sodium) injection.

The NDA proposes the use of Genasense plus fludarabine and cyclophosphamide for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to a company news release.

The FDA granted an action date for the filing on Oct. 28, 2006.

"This filing represents the first NDA for a drug that promotes chemotherapy-induced apoptosis in hematologic oncology. We plan to work closely with [the] FDA as we seek approval to commercialize this new treatment option for patients with advanced CLL," said Loretta M. Itri, president, pharmaceutical development and chief medical officer, in a company statement.

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment, the release said.

Genta said CLL is the most common form of leukemia in adults. According to the American Cancer Society, about 8,000 patients will be diagnosed this year. The disease arises in lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions.

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

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