You are here

Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

Book pagination

1.4. Binimetinib

Scheduling proposal

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.

Substance summary

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.

Table A: Binimetinib chemical information and naming
Property Binimetinib
CAS number 606143-89-9
Chemical structure
Molecular formula C17H15BrF2N4O3
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)

Scheduling status

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)).

International regulations

  • 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.

Delegate’s consideration

  • 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

BINIMETINIB.

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.

Book pagination