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Scheduling delegate's final decisions, January 2017
Scheduling medicines and poisons
Final decisions on matters not referred to an expert advisory committee
2. New Chemical Entities – medicines for human therapeutic use
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of lenvatinib, a new chemical entity (NCE) for a human therapeutic medicine.
Lenvatinib is a multiple receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET.
Lenvatinib is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.
AAN – Lenvatinib
Lenvatinib is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Lenvatinib is not classified in New Zealand.
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;
- The TGA evaluation report; and
- The new drug application.
Delegate's final decision
The delegate has made a final decision to amend the Poisons Standard to include lenvatinib 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
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; and (e) the potential for abuse.
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;
- Lenvatinib is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer;
- Toxicity was considered in TGA review of initial application and is addressed under benefit/risk balance above;
- The dosage, formulation, labelling, packaging and presentation were considered satisfactory in the TGA review of the initial application; and
- The potential for abuse was considered to be nil in a TGA review of the initial application.