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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 plitidepsin in Schedule 4 as follows:
Schedule 4 - New Entry
Appendix L - New Entry
Warning statements: 7 (WARNING - Causes birth defects), 62 (Do not use if pregnant), 63 (See a doctor if you are pregnant or diabetic), 76 (Do not become pregnant during use or within 6 months of stopping treatment), 87 (Plitidepsin remains in the body for many months after treatment has stopped. Do not become pregnant or father a child before consulting your doctor)
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:
It is a new cytotoxic chemical entity with no marketing experience in Australia.
- the purposes for which a substance is to be used and the extent of use of a substance:
Plitidepsin is used for the treatment of patients with relapsed or refractory multiple myeloma who have received at least three prior treatment regimens, including both a proteasome inhibitor and an immunomodulator. Aplidin may be used after two prior lines of therapy if refractory and/or intolerant to both a proteasome inhibitor and an immunomodulator.
- the toxicity of a substance:
Reported adverse effects from plitidepsin exposure include cytopaenias, elevation of creatine phosphokinase, liver enzyme derangement, cardiac rhythm disturbance and fatigue.
- the dosage, formulation, labelling, packaging and presentation of a substance:
Plitidepsin is presented as a powder for reconstitution and administered by intravenous injection.
- the potential for abuse of a substance:
There is no identified risk of abuse of plitidepsin outside the registered indication.
- 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 plitidepsin, a new chemical entity (NCE) for a human therapeutic medicine.
Plitidepsin is not specifically scheduled and is not captured by any entry in the Poisons Standard.
- Section 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework (SPF 2018) scheduling factors;
- The TGA evaluation report;
- The advice of the Advisory Committee Medicines; and
- The new drug application.