Part B - Final decisions on matters not referred to an expert advisory committee
5. New Chemical Entities - medicines for human therapeutic use
5.1 Olaratumab
On this page: Delegate's final decision | Scheduling proposal | Substance summary | Scheduling status | International regulations | Delegate's considerations
Delegate's final decision
Final decision:
The delegate has made a final decision to create a new Schedule 4 entry for olaratumab in the Poisons Standard as follow:
Schedule 4 - New Entry
OLARATUMAB.
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
- It is a new chemical entity with no marketing experience in Australia.
- the purposes for which a substance is to be used and the extent of use of a substance
- Nil.
- the dosage, formulation, labelling, packaging and presentation of a substance
- Nil.
- the toxicity of a substance
- Nil.
- the potential for abuse of a substance
- Nil.
- any other matters that the Secretary considers necessary to protect public health
- Nil.
Scheduling proposal
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of olaratumab, a new chemical entity (NCE) for a human therapeutic medicine.
Substance summary
Olaratumab is a monoclonal antibody developed for the treatment of solid tumors. It is directed against the platelet-derived growth factor receptor alpha.
Olaratumab is used to treat soft-tissue sarcoma (STS).
Scheduling status
Olaratumab is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) - the Poisons Standard that was in effect at the time the decision was made (Poisons Standard March 2018 (SUSMP No. 20)), 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.
International regulations
Olaratumab is a prescription medicines in the EU and the USA. Olaratumab is a Schedule D prescription medicine in Canada.
Olaratumab is unclassified in New Zealand.
Delegate's considerations
The delegate considered the following in regards to this application for scheduling:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework (2015) scheduling factors; and
- Orphan drug application.
The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.