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Scottish Medicines Consortium approve acute myeloid leukaemia treatment arsenic trioxide (Trisenox) for use by NHS Scotland

Trisenox, for Acute myeloid leukaemia from Teva UK Limited

The Scottish Medicines Consortium have approved Teva's acute promyelocytic leukaemia treatment arsenic trioxide, brand name Trisenox for use by NHS Scotland in adult patients.

This means that Trisenox will be funded by NHS Scotland and made available to patients who qualify.

Acute promyelocytic leukemia is an important sub-type of acute myeloid leukaemia. In this sub-type, chromosomal changes in promyelocytes - cells that are at an early stage in the development into mature neutrophils - allow accumulation of these immature cells.

Trisenox is approved as an option, in combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adult patients with newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count ≤10 x 103/µl), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.

In a Phase III study in patients with newly diagnosed, low-to-intermediate risk APL, arsenic trioxide was non-inferior to anthracycline-based chemotherapy (both in combination with tretinoin) measured by event-free survival. A significant difference in overall survival favouring arsenic trioxide was also demonstrated.

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About Trisenox (source EMA)
Trisenox is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation’ (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A). Patients with APL are normally treated with retinoids (substances derived from vitamin A).

Trisenox is used in:
  • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA).
  • Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
The active substance in Trisenox, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia. The way it works in this disease is not completely understood. It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.

Trisenox was first made available in the EU in 2002. It is manufactured by Teva.

European Medicines Agency website page for Trisenox
Links available in full article

SMC information on Trisenox

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

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