Review of the application is coordinated by the European medicines authority (EMEA). The procedure affords for a centralized authorization that is valid in all 25 member states of the European Community.
Genasense, Genta’s lead anticancer drug, 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.
“We believe that Genasense represents a breakthrough treatment for patients, and we look forward to continued dialogue with regulatory authorities in Europe,” commented Dr Raymond Warrell Jr, chairman and CEO of Genta.