Advice

following a resubmission:

arsenic trioxide (Trisenox®) is accepted for use within NHSScotland.

Indication under review: 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.

Medicine details

Medicine name:
arsenic trioxide (Trisenox)
SMC ID:
SMC2181
Indication:

For 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) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) 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.

Pharmaceutical company
Teva UK Limited
BNF chapter
Malignant disease and immunosuppression
Submission type
Resubmission
Status
Accepted
Date advice published:
08 July 2019