Genta completes marketing authorization application to EMEA for approval of Genasense in combination with chemotherapy
Genta Incorporated announced that the Company has completed a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) that seeks approval of Genasense® (oblimersen concentrate for solution for injection) in combination with chemotherapy for the treatment of patients with advanced malignant melanoma.
Genta expects that the dossier will be formally reviewed for validation at a meeting of the Committee for Medicinal Products for Human Use (CHMP) that is scheduled for January 23-26, 2006. Assuming validation, the initial review of the MAA would commence thereafter, and Genta would anticipate receiving consolidated questions from the Agency approximately 120 days later. The centralized licensing procedure provides a single marketing authorization that is valid in all 25 member states of the European Community. Review of the application is coordinated by the EMEA, and Spain and France have been appointed as rapporteur and co-rapporteur countries, respectively.
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.
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