EU CHMP recommends a change in authorisation for Trisenox (arsenic trioxide injection) in acute promyelocytic leukaemia- Teva

The EU's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Trisenox (arsenic trioxide injection) from Teva. The CHMP adopted changes to the existing indication as follows: Trisenox is indicated for induction of remission, and consolidation in adult patients with: 1. Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, below 10 x 10^3/micro litres) in combination with all-trans-retinoic acid (ATRA) 2. Relapsed/refractory acute promyelocytic leukaemia (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. The response rate of other acute myelogenous leukaemia subtypes to Trisenox arsenic trioxide has not been examined.