TRISENOX (arsenic trioxide), antineoplastic

High clinical benefit for the treatment of acute promyelocytic leukaemia in combination with all-trans retinoic acid and minor clinical added value compared to the all-trans retinoic acid - chemotherapy combination

• TRISENOX has been granted a marketing authorisation for remission induction and consolidation for adults suffering from newly diagnosed acute promyelocytic leukaemia (APL) at a low or intermediate risk (leukocyte count: ≤ 10 x 10³/μL), in combination with all-trans retinoic acid (ATRA or tretinoin), characterised by the presence of t(15;17) translocation and/or the presence of the PML/RAR-alpha gene.

• The superiority of the ATRA-arsenic trioxide combination has been demonstrated compared to the ATRA-chemotherapy combination in terms of 2-year event-free survival.

• No gain in overall survival or in quality of life has been demonstrated.

• The ATRA-arsenic trioxide combination is a first-line treatment for this indication.