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Scheduling delegate's final decisions, January 2018
Scheduling medicines and poisons
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of binimetinib, a new chemical entity (NCE) for a human therapeutic medicine.
Binimetinib is an orally available, ATP-uncompetitive, reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation (162-Enz-1). MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. Binimetinib has demonstrated potent activity against MEK 1/2 enzyme and possesses broad anti-proliferative activity in vitro and in vivo.
Binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma, with NRAS Q61 mutation.
|Molecular weight||441.2 g/mol|
|Chemical names||5-[(4-bromo-2-fluorophenyl)amino]-4-fluoro-N-(2-hydroxyethoxy)- 1-methyl-1H-benzimidazole-6-carboxamide|
|Other names||111235 (AAN); 10288191 (CID)|
Binimetinib is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – the Poisons Standard that was in effect at the time the decision was made (Poisons Standard October 2017 (SUSMP No. 18)).
- Application for approval of binimetinib was submitted to the United States of America Food and Drug Administration (FDA) for approval (2016). However, binimetinib is not yet FDA approved.
- The European Medicines Agency granted a deferral for binimetinib in 2016, agreeing on an investigation plan.
- Binimetinib is not classified in New Zealand and Canada.
- 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; and
- The TGA evaluation report.
The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.
Delegate’s final decision
The delegate has made a final decision to amend the Poisons Standard to include binimetinib in Schedule 4, with an implementation date of 1 February 2018.
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 1989are: (a) the risks and benefits of the use of a substance.
The delegate decided that the reasons for the final decision comprise the following:
- It is a new chemical entity with no marketing experience in Australia.