Trisenox

Trisenox is indicated 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) characterized 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. It is also indicated for adult patients with relapsed/refractory APL, where previous treatment included a retinoid and chemotherapy.

In APL patients, Trisenox demonstrated a morphological complete response in 11 out of 13 patients (85%). The overall complete response (CR) rate for adults was 89%, and for children, it was also 89%. Event-free survival (EFS) at 3 years was 77% in the As2O3 arm compared to 59% in the standard arm. Overall survival (OS) at 3 years was 86% in the As2O3 arm versus 77% in the standard arm.

Common safety findings included pyrexia (60%), nausea, vomiting, cough, and cancer pain (35%). Other reported adverse events included hypomagnesemia (26%), hypocalcemia (26%), and electrocardiogram QT prolonged (investigator attributed) (15%). The drug received approval in 2002, with a Type II variation application submitted on 9 March 2016 for a new therapeutic indication.