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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.2. Apalutamide

Scheduling proposal

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

Substance summary

Apalutamide is a potent androgen receptor (AR) antagonist that targets the AR ligand-binding domain and prevents AR nuclear translocation, DNA binding, and transcription of AR gene targets.

Unlike bicalutamide, apalutamide antagonised AR-mediated signalling in ARs overexpressing human castration-resistant prostate cancer cell lines. In mice bearing human castration-resistant prostate cancer xenografts, apalutamide produced dose-dependent tumor regressions superior to those achieved with bicalutamide or enzalutamide.

Apalutamide is intended to be indicated for the treatment of patients with castration-resistant prostate cancer at risk of developing metastases.

Scheduling status

Apalutamide is not specifically scheduled and is not captured by any entry 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 October 2017 (SUSMP No. 18)).

International regulations

Apalutamide does not appear to be scheduled internationally.

Delegate’s consideration

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 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 apalutamide in Schedule 4, with an implementation date of 1 February 2018.

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

Schedule 4 – New Entry

APALUTAMIDE.

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.

The delegate decided that the reasons for the final decision comprise the following:

  • Apalutamide is an NCE with no clinical/marketing experience in Australia.

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