The company now anticipates that agency will complete its review and issue its opinion regarding approval within the next 90 days.
Genasense is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma.
According to Genta, the application is based on long-term data derived from the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma.