Genta Incorporated has announced that the Food and Drug Administration (FDA), has made public the briefing documents for the Oncology Drug Advisory Committee's (ODAC) review of the New Drug Application (NDA) for Genasense (oblimersen sodium) Injection plus chemotherapy for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia. The ODAC meeting will be discussing the Genasense application on September 6, 2006 beginning at 8 00 am. EDT.
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. The company's research platform is anchored by two major programs that centre on oligonucleotides (RNA and DNA-based medicines) and small molecules. Genasense (oblimersen sodium) Injection is the company's lead compound from its oligonucleotide program. The company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma.