The US Food and Drug Administration has accepted Genta Incorporated's new drug application (NDA) 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 leukaemia (CLL). The filing was granted an action date by FDA under the Prescription Drug User Fee Act (PDUFA) of October 28, 2006, states the company release.

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

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 programme with Genasense evaluating its potential to treat various forms of cancer.

Genta is studying Genasense in multiple, late-stage, randomized and non-randomized clinical trials, including chronic lymphocytic leukaemia, acute myeloid leukaemia, malignant melanoma, non-small cell lung cancer, small cell lung cancer, and prostate cancer.

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer.