You are here

Scheduling delegates' final decisions: NCEs, May 2018

Scheduling medicines and poisons

19 June 2018

Book pagination

1.4 Daratumumab

New Chemical Entities - medicines for human therapeutic use

1.4 Daratumumab

Delegate's final decision
Final decision:

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

Schedule 4 - New Entry

DARATUMUMAB.

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.
Scheduling proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to daratumumab.

Scheduling status

Daratumumab is not specifically scheduled in Poisons Standard, but as a monoclonal antibody, it is captured by the Schedule 4 entry for monoclonal antibodies as follows:

Schedule 4

MONOCLONAL ANTIBODIES for therapeutic use except:

  1. in diagnostic test kits; or
  2. when separately specified in these Schedules.
Delegate's consideration

The delegate considered the following in regards to this scheduling:

  • 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.

Book pagination