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Genasense New Drug Application Accepted for Review by FDA |
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01 Mar 2006 |
BERKELEY HEIGHTS, NJ, USA | Mar 01, 2006 | Genta Incorporated (NASDAQ: GNTA) announced that the U. S. Food and Drug Administration (FDA) has accepted the Company’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 leukemia (CLL). The filing was granted an action date by FDA under the Prescription Drug User Fee Act (PDUFA) of October 28, 2006.
“This filing represents the first NDA for a drug that promotes chemotherapy-induced apoptosis in hematologic oncology, ” said Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “We plan to work closely with
FDA as we seek approval to commercialize this new treatment option for patients with advanced CLL.”
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. Genta is studying Genasense in multiple, late-stage, randomized and non-randomized clinical trials, including chronic lymphocytic leukemia, acute myeloid leukemia, malignant melanoma, non-small cell lung cancer, small cell lung cancer, and prostate cancer.
SOURCE: Genta Incorporated |
