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Scheduling delegates' final decisions: NCEs, May 2018

Scheduling medicines and poisons

19 June 2018

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1.5 Durvalumab

New Chemical Entities - medicines for human therapeutic use

1.5 Durvalumab

Delegate's final decision
Final decision:

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

Schedule 4 - New Entry

DURVALUMAB.

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
    • Durvalumab is an active chemical substance which has significant 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.
  2. the toxicity of a substance
    • Durvalumab can cause significant, potentially fatal toxicity.
Scheduling proposal

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

Scheduling status

Durvalumab is not specifically scheduled in the 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
  • 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; and (c) the toxicity of a substance.

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