You are here
Scheduling delegate's final decisions, January 2017
Scheduling medicines and poisons
Final decisions on matters not referred to an expert advisory committee
2. New Chemical Entities – medicines for human therapeutic use
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of carfilzomib, a new chemical entity (NCE) for a human therapeutic medicine.
Carfilzomib is an anti-cancer drug acting as a selective tetrapeptide epoxyketone proteasome inhibitor that irreversibly binds to the N- terminal threonine-containing actives sites of the 20S proteasome (the proteolytic core particle within the 26S proteasome). It has anti-proliferative and pro-apoptotic activities in vitro in solid and haematologic tumour cells. In animals, Carfilzomib inhibits proteasome activity in blood and tissue and delays tumour growth in models of multiple myeloma, haematologic, and solid tumours.
Carfilzomib is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy.
|Molecular weight||719.91 g/mol|
|Chemical name/s||(2S)-4-Methyl-N-[(2S)-1-[[(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide (IUPAC)|
|ANN/INN||Carfilzomib (ANN and INN)|
Carfilzomib is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Carfilzomib in unclassified in New Zealand and Canada.
Carfilzomib is a prescription medicine in the United States of America.
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 Carfilzomib 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
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; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.
The delegate decided that the reasons for the final decision comprise the following:
- Carfilzomib is an NCE with no clinical/marketing experience in Australia.
- Carfilzomib is indicated for the treatment of relapsed/refractory multiple myeloma.
- Carfilzomib has reported adverse events of pulmonary toxicity, pulmonary hypertension, hypertension, tumour lysis syndrome, haemorrhage and thrombocytopaenia, venous thrombosis, hepatic toxicity and posterior reversible encephalopathy syndrome.
- Carfilzomib is administered intravenously, and has a complex administration schedule.
- The potential for abuse of Carfilzomib is unlikely.