4.3. Abemaciclib

Final decision

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

Implementation date

1 June 2019

Reasons

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:

   Nil

4. the dosage, formulation, labelling, packaging and presentation 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