Genta Incorporated announced that the company has filed an appeal of the recent negative decision by the Food and Drug Administration's (FDA) Office of Oncology Drug Products (OODP) regarding the company's New Drug Application (NDA) for Genta's lead oncology product, Genasense (oblimersen sodium) Injection. The NDA proposed the use of Genasense in combination with chemotherapy as treatment for patients with relapsed or refractory chronic lymphocytic leukaemia (CLL).
"We believe our amended application provided evidence that amply documented the safety and effectiveness of Genasense for patients with CLL," said Dr Raymond P Warrell, Genta's chairman and chief executive officer. "We look forward to promptly meeting with senior FDA leadership to formally review the key issues of this NDA."
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 to evaluate its potential to treat various forms of 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.