DIR 217 Commercial supply of nadofaragene firadenovec for bladder cancer treatment

Overview

The Gene Technology Regulator has received a licence application (DIR 217) from Ferring Pharmaceuticals Pty Ltd for commercial supply of a genetically modified (GM) therapeutic for bladder cancer treatment.

Comments are now being sought on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) that has been prepared by the Office of the Gene Technology Regulator (OGTR). The draft RARMP and other relevant documents can be viewed in the related attachments below.

Note: No personally identifying information will be released as part of your submission. Deidentified submissions summaries will be included in the finalised RARMP. Your personal information is protected by law, including the Privacy Act 1988 and the Australian Privacy Principles. More information about OGTR’s privacy policy can be found on our website.