DIR 132

Commercial supply of a tumour-selective genetically modified virus for cancer therapy

Licence details

Licence number:
DIR 132
Licence status:

Amgen Australia Pty Ltd

Parent organism:

Herpes simplex virus-1

Modified trait:

Therapeutic – attenuation, therapeutic – enhanced immune response

Licence issue date:

This licence allows Amgen Australia Pty Ltd to commence the commercial supply of a tumour-selective genetically modified virus for cancer therapy. The GM virus has been modified by removing two viral replication genes, substantially reducing its ability to reproduce and spread beyond the (injected) tumour tissue. Additionally, a viral gene which helps the virus evade the immune system has been removed, and a gene encoding a human protein that stimulates some types of immune cells has been introduced.

The GMO is intended for use as a prescription only treatment for patients with skin cancer (metastatic melanoma) and other suitable solid tumours that are unable to be removed by surgery. The Risk Assessment and Risk Management Plan (RARMP) did not identify any substantive risks to people or the environment. The GMO has been used in clinical trials on skin cancer and several types of advanced solid tumours in multiple countries, including the United Kingdom, Canada, South Africa, the USA and Australia. Commercial supply of the GM virus in Australia will follow the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 (2011), the WHO’s Good Distribution Practices for pharmaceutical products (WHO 2010), and the Standard for the Uniform Scheduling of Medicines and Poisons (as current) which all provide appropriate controls and informed the risk assessment. Any unused vaccine or waste material will be disposed of in accordance with local requirements for clinical waste.

The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:


Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Risk assessment and risk management plan - summary

A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.

Risk assessment and risk management plan - full version

The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.