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Final decisions and reasons for NCEs, medicines and chemicals, November 2018
Scheduling medicines and poisons
Part B - Final decisions on matters not referred to an expert advisory committee
4. New Chemical Entities - medicines for human therapeutic use
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Delegate's 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
1 June 2019
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:
- 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.
- 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.
- the toxicity of a substance:
- the dosage, formulation, labelling, packaging and presentation of a substance:
- the potential for abuse of a substance:
- any other matters that the Secretary considers necessary to protect public health:
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.
Abemaciclib is not specifically scheduled and is not captured by any entry in the Poisons Standard.
- Section 52E(1) of the Therapeutic Goods Act 1989;
- Scheduling Policy Framework (SPF 2018); and
- Advice on the place in therapy of this NCE.