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Scheduling delegate's final decisions, January 2017

Scheduling medicines and poisons

16 January 2017

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2.5. Talimogene laherparepvec

Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – medicines for human therapeutic use

2.5. Talimogene laherparepvec

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of talimogene laherparepvec, a new chemical entity (NCE) for a human therapeutic medicine.

Substance summary

Talimogene laherparepvec is a modified herpes simplex virus type 1 (HSV-1) encoding GM-CSF.

Talimogene laherparepvec is indicated for the treatment of melanoma that is regionally or distantly metastatic.

ABN – Talimogene laherparepvec

Scheduling status

Talimogene laherparepvec is not specifically scheduled and is not captured by any entry in the current Poisons Standard.

International regulations

Talimogene laherparepvec is not classified in New Zealand.

Delegate's consideration

The delegate made a delegate-only decision; hence the Advisory Committee on Medicines Scheduling was not consulted.

The delegate considered the following in regards to this application for scheduling:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (2015) scheduling factors; and
  • The TGA evaluation report;
  • The advice of the Advisory Committee on Prescription Medicines;
  • The new drug application; and
  • Other [OGTR reports].
Delegate's final decision

The delegate has made a final decision to amend the Poisons Standard to include talimogene laherparepvec in Schedule 4, with an implementation date of 1 February 2017.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule 4 – New Entry

TALIMOGENE LAHERPAREPVEC.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse; and (f) any other matters that the Secretary considers necessary to protect public health.

The delegate decided that the reasons for the final decision comprise the following:

  • Benefit/risk balance is considered positive for the approved use, but there is limited clinical experience with the product in Australia;
  • talimogene laherparepvec is indicated as monotherapy for the treatment of melanoma in patients with unresectable cutaneous, subcutaneous or nodal lesions after initial surgery;
  • Toxicity was considered in TGA review of initial application and is addressed under benefit/risk balance above;
  • Dosage, formulation, labelling, packaging and presentation were considered satisfactory in a TGA review of the initial application;
  • The potential for abuse was considered to be nil in a TGA review of the initial application;
  • Environmental/person-to-person spread considered under benefit/risk balance above.

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