New Chemical Entities - medicines for human therapeutic use
1.2 Avelumab
On this page: Delegate's final decision | Scheduling proposal | Scheduling status | Delegate's consideration
Delegate's final decision
Final decision:
The delegate's final decision is to amend the Poisons Standard to include avelumab in Schedule 4 as follows:
Schedule 4 - New Entry
AVELUMAB.
Implementation date: 1 June 2018
Reasons:
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:
- the risks and benefits of the use of a substance
- Avelumab is an active chemical substance which has significant risks. The risk-benefit balance for an individual patient, including explanation of the risks in order for the balance to be understood, requires the input of a medical practitioner.
- the toxicity of a substance
- Avelumab can cause significant, potentially fatal toxicity
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to avelumab.
Scheduling status
Avelumab is not specifically scheduled in the Poisons Standard, but as a monoclonal antibody, it is captured by the Schedule 4 entry for monoclonal antibodies as follows:
Schedule 4
MONOCLONAL ANTIBODIES for therapeutic use except:
- in diagnostic test kits; or
- when separately specified in these Schedules.
Delegate's consideration
The delegate considered the following in regards to this scheduling:
- Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; and (c) the toxicity of a substance.