Genta files application with FDA for Genasense plus chemotherapy for leukemia

By Angela McDaniels

Seattle, Dec. 29 - Genta Inc. said it has completed the filing of a New Drug Application with the Food and Drug Administration for its lead anti-cancer drug Genasense (oblimersen sodium) Injection.

The application proposes the use of Genasense plus fludarabine and cyclophosphamide as treatment for patients with relapsed or refractory chronic lymphocytic leukemia.

The application has received fast track and accelerated approval designations. If it is selected for priority review, an approval action will likely occur within six months, Genta said.

The NDA contains safety and efficacy data from a 40-patient phase 1/2 trial of Genasense, safety and efficacy data from a phase 3 study of 241 patients who received fludarabine and cyclophosphamide with or without Genasense and safety data from about 1,000 additional patients who have received Genasense in other clinical trials.

The phase 3 trial was designed to test whether the addition of Genasense to standard chemotherapy would significantly increase the proportion of patients who achieved a complete or nodular partial response.

Genta said the trial met its primary endpoint: the addition of Genasense increased the proportion of patients who achieved a complete or nodular partial response from 7% in the chemotherapy-only arm to 17% in the Genasense arm.

All responses in both trial arms exceeded six months in duration, and patients experienced substantial clinical benefit, including but not limited to relief of all disease-related symptoms and normalization of blood counts, the company said.

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

Chronic lymphocytic leukemia is the most common form of leukemia in adults. More than 60,000 people in the United States currently have the disease, Genta said, and disease-related problems such as a generalized depression of immunity and impaired production of normal blood cells often lead to life-threatening complications such as overwhelming infections and fatal bleeding.

Genta is a biopharmaceutical company based in Berkeley Heights, N.J., that develops oncology drugs based on oligonucleotides and small molecules.

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