Genasense receives Orphan Drug designation in Australia

19-Oct-2006

Genta Incorporated announced that its lead anticancer drug, Genasense (oblimersen), has received Orphan Drug Designation from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia. The designation was granted for the use of Genasense as treatment for patients with Stage IV malignant melanoma. Orphan Drug designation is intended to facilitate the development of drugs that address significant unmet medical needs, and it provides 7 years of market exclusivity after approval, grants and tax credits for research and development, and reduced filing fees for marketing applications.

Genta has filed a Marketing Authorization Application (MAA) that is currently under review with the European Medicines Agency (EMEA) for the use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. That application, which follows the same format that would be required for an Australian submission, is comprised of results from a randomized multinational trial of dacarbazine with or with Genasense in patients with advanced melanoma.

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