Genta completes malignant melanoma NDA

Genta, from Berkeley Heights, NJ, has completed the submission of its New Drug Application (NDA) for Genasense (oblimersen sodium) used in combination with dacarbazine for the treatment of patients with advanced malignant melanoma.

The application process, which began in the 3rd quarter of 2003, was submitted under the Fast Track program of the FDA that is designed to expedite review of new drugs that

address important unmet medical needs. The company has requested designation of the

Genasense NDA for Priority Review. Applications that are granted priority review are usually targeted for action by the FDA within six months from the date the submission is completed.

About Genasense

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatments. Based on preclinical and clinical studies that demonstrate anti-tumor effects in a broad range of cancers, Genta is studying Genasense in multiple, late-stage randomized and non-randomized clinical trials, including multiple myeloma, chronic lymphocytic leukemia, non-small cell lung cancer, small cell lung cancer, and prostate cancer.

About malignant melanoma

Malignant melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4% annually in the US. In 2003, the American Cancer Society estimates more than 54,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of cancer death in women aged 25 to 29.