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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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4.4. Plitidepsin

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

4. New Chemical Entities - medicines for human therapeutic use

4.4. Plitidepsin

Note

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Delegate's final decision
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

PLITIDEPSIN

Appendix L - New Entry

PLITIDEPSIN

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

PLITIDEPSIN

Schedule 4

Appendix L

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:

    It is a new cytotoxic chemical entity with no marketing experience in Australia.

  2. 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.

  3. 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.

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

    Plitidepsin is presented as a powder for reconstitution and administered by intravenous injection.

  5. the potential for abuse of a substance:

    There is no identified risk of abuse of plitidepsin outside the registered indication.

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

    Nil

Scheduling proposal

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.

Scheduling status

Plitidepsin 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;
  • The Scheduling Policy Framework (SPF 2018) scheduling factors;
  • The TGA evaluation report;
  • The advice of the Advisory Committee Medicines; and
  • The new drug application.

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