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Final decisions and reasons for NCEs, medicines and chemicals, November 2018

Scheduling medicines and poisons

26 April 2019

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4.3. Abemaciclib

Part B - Final decisions on matters not referred to an expert advisory committee

4. New Chemical Entities - medicines for human therapeutic use

4.3. Abemaciclib


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Delegate's final decision
Final decision

The delegate's final decision is to amend the Poisons Standard to include abemaciclib in Schedule 4 as follows:

Schedule 4 - New Entry


Index - New Entry


Schedule 4

Implementation date

1 June 2019


The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:

  1. the risks and benefits of the use of a substance:

    As per palbociclib which is Schedule 4.

    Benefit: Improvement in PFS (Progression Free Survival - length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease without it getting worse).

    Risks: VTE (Venous thromboembolism), diarrhoea, neutropenia.

  2. the purposes for which a substance is to be used and the extent of use of a substance:

    Abemaciclib is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy (MONARCH-2,3).

    In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

  3. the toxicity of a substance:


  4. the dosage, formulation, labelling, packaging and presentation of a substance:


  5. the potential for abuse of a substance:


  6. any other matters that the Secretary considers necessary to protect public health:


Scheduling proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to abemaciclib, a new chemical entity (NCE) for a human therapeutic medicine.

Scheduling status

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

Delegate's considerations
  • Section 52E(1) of the Therapeutic Goods Act 1989;
  • Scheduling Policy Framework (SPF 2018); and
  • Advice on the place in therapy of this NCE.

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