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Final decisions amending, or not amending, the current Poisons Standard, April 2018

Scheduling medicines and poisons

10 April 2018

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5.1 Olaratumab

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

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:

  1. the risks and benefits of the use of a substance
    • It is a new chemical entity with no marketing experience in Australia.
  2. the purposes for which a substance is to be used and the extent of use of a substance
    • Nil.
  3. the dosage, formulation, labelling, packaging and presentation of a substance
    • Nil.
  4. the toxicity of a substance
    • Nil.
  5. the potential for abuse of a substance
    • Nil.
  6. 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:

  1. in diagnostic test kits; or
  2. 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.

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