Basic Information
Arsenic trioxide Accord
Regulatory Information
EMEA/H/C/005175
November 14, 2019
September 19, 2019
7
December 5, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Arsenic trioxide is indicated for 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/?l) in combination with all-trans-retinoic acid (ATRA) - 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 promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
Overview Summary
Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation’ (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A). Patients with APL are normally treated with retinoids (substances derived from vitamin A). Arsenic trioxide Accord is used in: - Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid. - Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment. Arsenic trioxide Accord contains the active substance arsenic trioxide and is a ‘generic medicine’. This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Trisenox.