1.1. Alectinib

Scheduling proposal

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

Substance summary

Alectinib is a second generation oral drug that selectively inhibits the activity of anaplastic lymphoma kinase (ALK) tyrosine kinase. It is specifically used in the treatment of non-small cell lung cancer (NSCLC) expressing the ALK-EML4 (echinoderm microtubule-associated protein-like 4) fusion protein that causes proliferation of NSCLC cells. Inhibition of ALK prevents phosphorylation and subsequent downstream activation of STAT3 and AKT resulting in reduced tumour cell viability.

Alectinib is indicated for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), who have progressed on or are intolerant to crizotinib.

Scheduling status

Alectinib 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

Alectinib is classified as a prescription only medicine in New Zealand, the United States of America 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;
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 alectinib 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

ALECTINIB.

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; and (c) the toxicity of a substance.

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

Alectinib is a new chemical entity with limited marketing experience in Australia.
Alectinib has significant capacity for toxicity without benefit outside its proposed usage.

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