Genta Incorporated (Nasdaq: GNTA)’s lead anticancer drug, Genasense® (oblimersen), has received Orphan Drug designation from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia, as treatment for patients with Stage IV malignant melanoma.
According to Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer:
"Melanoma is an especially serious public health problem in Australia.
The recently published Phase 3 study of Genasense plus dacarbazine included a large number of Australian participants and showed benefit across an array of clinical endpoints.
Genta has retained a local agent in Australia to represent the Company before the TGA, and we are very pleased that the TGA has granted the requested designation in melanoma.
We will decide whether to proceed with a formal marketing application pending further discussions with regulatory authorities."
A Marketing Authorization Application (MAA) filed by Genta is currently under review with the European Medicines Agency (EMEA) for the use of Genasense plus dacarbazine for treatment of patients with advanced melanoma.
The said MAA, 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.
Find more details from the press release.
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