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Marketing authorization without orphan designation - Europe

Therapeutic indication

TRISENOX 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/μl) 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 Pro-Myelocytic 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.

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