Genta Incorporated announced that the company 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 on December 8, 2003.
The application process, which began in the 3rd quarter of this year, was submitted under the Fast Track program of the US Food and Drug Administration (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. The FDA usually targets applications that are granted priority review for action within six months from the date the submission is completed.
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-tumour 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.
Malignant melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4 per cent 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.
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.