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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 elotuzumab, a new chemical entity (NCE) for a human therapeutic medicine.
Elotuzumab is a humanised, IgG1 monoclonal antibody (mab) that specifically binds to human Signalling Lymphocyte Activation molecule family member 7 (SLAMF7) proteins. It consists of the complimentary determining regions of the parent mouse antibody, MuLuc63, grafted onto human IgG1 heavy chain and kappa light chain regions. SLAMF7 is highly expressed in MM cells independent of diseases stage or cytogenetic abnormalities. SLAMF7 is also expressed on natural killer (NK) cells, natural killer T cells (NKT), plasma cells and on specific immune subsets (CD8+T and CD4+ T cells) but is not detected on hematopoietic stem cells or on most normal tissues. Binding of elotuzumab to NK cells directly activates immune cells through both the SLAMF7 and CD16 pathways enhancing anti-myeloma activity in vitro. Elotuzumab also binds to the SLAMF7 protein on myeloma cells and facilitates the interaction of NK cells with myeloma cells to mediate the killing of these malignant cells through antibody-dependent cellular cytotoxicity (ADCC). In preclinical models, elotuzumab has single-agent anti-MM activity and can synergize with lenalidomide and bortezomib to further enhance this activity.
Elotuzumab is indicated as a combination therapy for the treatment of multiple myeloma in adult patients who have received one or more prior therapies.
AAN – Elotuzumab
Elotuzumab is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Elotuzumab is not classified in New Zealand.
The delegate made a delegate-only decision; hence 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 elotuzumab 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; and (b) the purpose and the extent of use of a substance.
The delegate decided that the reasons for the final decision comprise the following:
- It is a NCE with no clinical/marketing experience in Australia;
- Elotuzumab has risks of infections, second primary malignancies, hepatotoxicity and infusion related reactions;
- Treatment should be initiated and supervised by physicians experienced in the treatment of multiple myeloma;
- Elotuzumab is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy; and
- The potential for abuse of elotuzumab is unlikely.