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Scheduling delegate's final decisions, January 2017

Scheduling medicines and poisons

16 January 2017

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2.12. Ixazomib

Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – medicines for human therapeutic use

2.12. Ixazomib

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of ixazomib (as citrate), a NCE for a human therapeutic medicine.

Substance summary

Ixazomib (as citrate) is a 20S proteasome inhibitor for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy. It is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy.

AAN – Ixazomib/ixazomib citrate

Scheduling status

Ixazomib (as citrate) is not specifically scheduled and is not captured by any entry in the current Poisons Standard.

International regulations

Ixazomib (as citrate) is not classified in New Zealand.

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 ixazomib 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

IXAZOMIB.

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 (b) the purpose and the extent of use of a substance.

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

  • It is a NCE with no clinical/marketing experience in Australia;
  • Ixazomib has risks of neuropathy, infections, neutropaenia and thrombocytopaenia;
  • Treatment should be initiated and supervised by physicians experienced in the treatment of multiple myeloma;
  • Ixazomib is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy; and
  • The potential for abuse of ixazomib is unlikely.

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