New Chemical Entities - medicines for human therapeutic use
1.7 Inotuzumab Ozogamicin
On this page: Delegate's final decision | Scheduling proposal | Scheduling status | Delegate's consideration
Delegate's final decision
Final decision:
The delegate's final decision is to amend the Poisons Standard to include inotuzumab ozogamicin in Schedule 4 as follows:
Schedule 4 - New Entry
INOTUZUMAB OZOGAMICIN.
Implementation date: 1 June 2018
Reasons:
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:
- the risks and benefits of the use of a substance
- Inotuzumab ozogamicin is a new chemical entity with no marketing experience in Australia. The risk-benefit balance at a population level has been considered, with the overall balance of benefits considered to outweigh the risks. The risk-benefit balance for an individual patient, including explanation of the risks in order for the balance to be understood, requires the input of a medical practitioner.
- the purposes for which a substance is to be used and the extent of use of a substance
- The extent of use of inotuzumab ozogamicin is considered to be relatively more limited compared to other therapeutic products. The intended purpose for use is in the treatment of adults with relapsed or refractory CD22-positive B-Cell precursor lymphoblastic leukaemia.
- the toxicity of a substance
- There are known risks and toxicities associated with the use of inotuzumab ozogamicin. The risk-benefit balance for an individual patient, including explanation of the risks in order for the balance to be understood, requires the input of a medical practitioner.
- the dosage, formulation, labelling, packaging and presentation of a substance
- The dosage, formulation, labelling, packaging and presentation have been considered and none of these aspects precludes scheduling as a Schedule 4 medicine.
- the potential for abuse of a substance
- The potential for abuse of inotuzumab ozogamicin is considered to be low.
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to inotuzumab ozogamicin.
Scheduling status
Inotuzumab ozogamicin is not specifically scheduled in the Poisons Standard, but as it is composed of a monoclonal antibody, it is captured by the Schedule 4 entry for monoclonal antibodies as follows:
Schedule 4
MONOCLONAL ANTIBODIES for therapeutic use except:
- in diagnostic test kits; or
- when separately specified in these Schedules.
Delegate's consideration
The delegate considered the following in regards to this scheduling:
- Advice on the place in therapy of this medicine;
- Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance.