DIR 217 Commercial supply of nadofaragene firadenovec for bladder cancer treatment

Between 24 July and 18 September 2025, we sought your feedback on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) prepared for the DIR 217 licence application (Commercial supply of genetically modified therapeutic from Ferring Pharmaceuticals Pty Ltd).

During the 8-week consultation period, we received advice from prescribed Government agencies, the Gene Technology Technical Advisory Committee, and the public.

We heard support for:

• the thoroughness of the RARMP
• the overall conclusions of the RARMP
• the inclusion of post-release review in the draft licence conditions.

Some submissions sought clarification on prevalence and serotyping of human adenoviruses in Australia.

We analysed the feedback provided during the public consultation process in finalising the RARMP. The issues raised and how they were addressed can be found in Appendices B and C of the final RARMP.

The Gene Technology Regulator issued a licence to Ferring Pharmaceuticals Pty Ltd for the commercial supply on 17 October 2025. More details, including the final version of the RARMP and the licence, are available at DIR 217 | Office of the Gene Technology Regulator.

We appreciate all those who provided input to the consultation – your feedback will help to ensure that any risks posed by gene technology to people and the environment continue to be managed.