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FDA-approved gene therapy nears
Posted 30 January 2026 AM
Ferring Pharmaceuticals hopes to conduct Phase 3 studies of nadofaragene firadenovec in Australia after securing a licence from the Office of Gene Technology Regulator (OGTR) in October that allows the ongoing commercial supply of the gene therapy in Australia.
While the pharma is yet to make a submission to the TGA, the therapy was approved in the US in 2022 under the brand name Adstiladrin for the treatment of adults with high-risk Bacillus Calmette Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours. It’s the first intravesical gene therapy approved for the condition.
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Posted 30 January 2026 AM
Ferring Pharmaceuticals hopes to conduct Phase 3 studies of nadofaragene firadenovec in Australia after securing a licence from the Office of Gene Technology Regulator (OGTR) in October that allows the ongoing commercial supply of the gene therapy in Australia.
While the pharma is yet to make a submission to the TGA, the therapy was approved in the US in 2022 under the brand name Adstiladrin for the treatment of adults with high-risk Bacillus Calmette Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours. It’s the first intravesical gene therapy approved for the condition.
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