1.4 Daratumumab

Final decision:

The delegate's final decision is to amend the Poisons Standard to include daratumumab in Schedule 4 as follows:

Implementation date: 1 June 2018

Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

1. the risks and benefits of the use of a substance
   • The risks and benefits have been considered, with the view reached that benefits outweighed risks at a population level in the proposed indication.
2. the purposes for which a substance is to be used and the extent of use of a substance
   • The extent of use of daratumumab is relatively limited, it is to be used:
     • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
     • as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent.
3. the toxicity of a substance
   • While daratumumab has distinct toxicities, these are well characterised and (given the benefits conferred in the target population) are consistent with scheduling as a Schedule 4 medicine.
4. the dosage, formulation, labelling, packaging and presentation of a substance
   • The dosage, formulation, labelling, packaging and presentation of daratumumab have been considered, and none of these aspects precludes scheduling as a Schedule 4 medicine.
5. the potential for abuse of a substance
   • There is low potential for abuse of daratumumab.