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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 cobimetinib, a NCE for a human therapeutic medicine.
Cobimetinib is a highly selective allosteric inhibitor that targets MEK1 and MEK2 tyrosine-threonine kinases. It has shown high inhibitory potency in biochemical and cell based assays, as well as broad anti-tumour activity in vivo in xenograft tumour models, including those that are mutated for BRAF and KRAS.
Cobimetinib is indicated for use in combination with vemurafenib for the treatment of patients with un-resectable or metastatic melanoma with BRAF V600 mutation.
AAN – Cobimetinib
Cobimetinib is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Cobimetinib is not classified in New Zealand.
The delegate decided to make a delegate-only decision. 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 cobimetinib 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;
- cobimetinib is indicated for use in combination with vemurafenib for the treatment of patients with un-resectable or metastatic melanoma with BRAF V600 mutation;
- 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 a TGA review of the initial application; and
- The potential for abuse was considered to be nil by the TGA when reviewing the initial application.