The company is seeking approval for the use of Genasense plus fludarabine and cyclophosphamide for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
“This filing represents the first NDA for a drug that promotes chemotherapy-induced apoptosis in hematologic oncology,” said Dr Loretta Itri, Genta’s 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.”
Genasense works by inhibiting 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.
In addition to chronic lymphocytic leukemia, Genta is also studying Genasense in multiple, late-stage clinical trials, including acute myeloid leukemia, malignant melanoma, non-small cell lung cancer, small cell lung cancer, and prostate cancer.