EU grants indication extension for Trisenox (arsenic trioxide) in Acute Promyelocytic Leukemia- Teva Pharmaceutical
Teva Pharmaceutical has obtained approval from the European Commission for an indication extension of Trisenox (arsenic trioxide) in treatment for Acute Promyelocytic Leukemia (APL) patients. The indication extension is for newly diagnosed low to intermediate risk Acute Promyelocytic Leukemia (APL) in combination with retinoic acid.
It is the first time that a form of acute leukemia can be effectively treated with a regimen that is entirely chemotherapy-free. APL is a rare and aggressive type of acute leukemia that can kill within hours or days if left untreated. Trisenox, in combination with retinoic acid, has shown a 99% overall survival rate with almost no relapses after more than four years (50 months) of median follow-up. This decision was made based solely on published academic research and studies.