Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved TRISENOX opvejer risiciene ved induktion af remission og konsolidering hos voksne patienter med recidiverende/ refraktær akut promyelocyt leukæmi, kendetegnet ved tilstedeværelsen af t( 15; 17) - translokationen og/ eller tilstedeværelsen af genet Promyelocytisk leukæmi/ Retinoinsyrereceptor- alfa (PML/ RAR- alfa), når tidligere behandling har omfattet et retinoid og kemoterapi.
The Committee for Medicinal products for Human Use (CHMP) decided that TRISENOX’ s benefits are greater than its risks for induction of remission and consolidation in adult patients with relapsed/ refractory APL, 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, when previous treatment has included a retinoid and chemotherapy.