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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.18. Ribociclib

Scheduling proposal

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

Substance summary

Ribociclib is an orally available cyclin-dependent kinase (CDK) inhibitor targeting cyclin D1/CDK4 and cyclin D3/CDK6 cell cycle pathway, with potential antineoplastic activity.

Ribociclib is indicated for advanced breast cancer.

Table J: Ribociclib chemical information and naming
Property Ribociclib
CAS number 1211441-98-3
Chemical structure
Molecular formula C23H30N8O
Molecular weight 434.6 g/mol
Chemical names 7-cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
Other names Ribociclib (ANN and INN); CDK4/6 inhibitor LEE011

Scheduling status

Ribociclib 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

Ribociclib is not classified in New Zealand and Canada and is a prescription only medicine in the United States of America and the European Union.

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 advice of the Advisory Committee on Prescription Medicines; and
  • The new drug application.

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 ribociclib 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

RIBOCICLIB.

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.

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

  • Ribociclib is a new chemical entity with no marketing experience in Australia.

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