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Scheduling delegate's final decisions, January 2017

Scheduling medicines and poisons

16 January 2017

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2.9. Osimertinib

Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – medicines for human therapeutic use

2.9. Osimertinib

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of osimertinib, a NCE for a human therapeutic medicine.

Substance summary

For the delegate to consider the scheduling of the NCE, osimertinib.

Osimertinib is an irreversible inhibitor of mutant forms of epidermal growth factor receptor (EGFR) found in non-small cell lung cancer (NSCLC).

Osimertinib is indicated for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer.

AAN – Osimertinib

Scheduling status

Osimertinib is not specifically scheduled and is not captured by any entry in the current Poisons Standard.

International regulations

Osimertinib is not classified in New Zealand.

Delegate's consideration

The delegate made a delegate-only decision, hence the Advisory Committee on Medicines Scheduling was not consulted.

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;
  • The TGA evaluation report; and
  • The new drug application.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegate's final decision

The delegate has made a final decision to amend the Poisons Standard to include osimertinib in Schedule 4, with an implementation date of 1 February 2017.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule 4 – New Entry

OSIMERTINIB.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse. The delegate decided that the reasons for the final decision comprise the following:

  • It is a new chemical entity with limited clinical experience in Australia;
  • The conclusion of the TGA evaluation was that a positive benefit / risk balance exists in the specified target population;
  • Osimertinib is indicated for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer; and
  • The potential for abuse of osimertinib is unlikely.

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