Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Genta has revealed that its lead anticancer drug Genasense for patients with melanoma has received orphan drug designation from the Therapeutic Goods Administration, the regulatory authority in Australia.
Subscribe to our email newsletter
The designation was granted for the use of Genasense for patients with stage IV malignant melanoma. Orphan drug designation is intended to facilitate the development of drugs that address significant unmet medical needs.
The status provides seven years of market exclusivity after approval, grants and tax credits for research and development and reduced filing fees for marketing applications.
“Melanoma is an especially serious public health problem in Australia,” said Dr Raymond Warrell, Genta's CEO. “The recently published phase III study of Genasense plus dacarbazine included a large number of Australian participants and showed benefit across an array of clinical endpoints.”
Genta has filed a marketing authorization application that is currently under review with the European Medicines Agency for the use of Genasense plus dacarbazine for treatment of patients with advanced melanoma.