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Confirmatory Clinical Trial for Oblimersen Requested by FDA

BERKELEY HEIGHTS, N.J., March 6, 2009 --(BUSINESS WIRE)--Genta Incorporated (NASDAQ: GNTA - News) announced that the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has decided that available data are not adequate to support approval of Genasense (oblimersen sodium) Injection for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In a decision issued in response to an appeal filed by Genta in December 2008, CDER concluded that new information submitted by the Company in its amended New Drug Application (NDA) was insufficient, and the Agency has recommended conducting a confirmatory clinical trial.

“While disappointed with this decision, we appreciate FDA’s clarification of the path to U.S. regulatory approval in this important indication,” commented Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “The Company will discuss this decision with clinical and regulatory authorities before determining our next steps. Genta greatly appreciates the professional and collaborative communications with FDA during this process, and we look forward to working with FDA in addressing their recommended options for securing the confirmatory data.”

About Genasense
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. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

Source: Genta Incorporated

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