Genta Appeals FDA Decision on Genasense NDA

Genta has filed a formal appeal of the recent decision by the FDA that the company's new drug application (NDA) for Genasense is not approvable, Genta announced.

The NDA proposed the use of Genasense (oblimersen sodium) in combination with chemotherapy for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

After the FDA's Oncologic Drugs Advisory Committee recommended against approving the application in September 2006, the the FDA sent Genta a not approvable letter in December. The company submitted its appeal in accordance with the formal dispute resolution process that exists within FDA's Center for Drug Evaluation and Research (CDER). Responses to CDER appeals are typically made within 30 to 60 days, according to the company.

The NDA is based on a Phase III trial in which patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide chemotherapy with or without Genasense. This trial -- the first randomized study ever conducted in this population -- achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response. The duration of complete response was significantly longer for patients treated with Genasense. In addition, the number, type and severity of adverse reactions encountered with Genasense were comparable to those with other leukemia drugs.

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis. 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.