25 July 2025

Invitation to comment on commercial supply of genetically modified therapeutic for bladder cancer treatment (DIR 217)

The Gene Technology Regulator (Regulator) has received an application from Ferring Pharmaceuticals Pty Ltd (Ferring) for the commercial supply of a genetically modified human adenovirus for treatment of bladder cancer.

The GM therapeutic contains a modified virus, which requires Ferring to seek review from both the Regulator and the Therapeutic Goods Administration before it is able to be used in Australia.

The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and welcomes written submissions on any risks to human health and the environment posed by the import, transport, storage and disposal of this GM therapeutic and is seeking comment on the RARMP prior to making a decision on whether or not to issue the licence. 

The consultation RARMP and related information can be obtained via the consultation hub at https://consultations.health.gov.au/ogtr/dir-217, or from the contacts below. Submissions should reference DIR 217 and be received by 18 September 2025.

Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601

Telephone: 1800 181 030   Website: www.ogtr.gov.au

E-mail: ogtr@health.gov.au