# PML::RARA in acute myeloid leukaemia

4 EU-approved indications in acute myeloid leukaemia need a PML::RARA result: arsenic trioxide (induction), arsenic trioxide (induction), arsenic trioxide (consolidation) and arsenic trioxide (consolidation).

## Approved indications

### PML::RARA fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Arsenic trioxide](https://oncolabels.com/drugs/arsenic-trioxide) (Trisenox) | PML::RARA fusion (defines the disease) | + all-trans-retinoic acid (ATRA) | Induction | Acute promyelocytic leukaemia only; Low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl |
| [Arsenic trioxide](https://oncolabels.com/drugs/arsenic-trioxide) (Trisenox) | t(15;17) translocation or PML/RAR-alpha gene | Monotherapy | Induction | Acute promyelocytic leukaemia only; After previous treatment should have included a retinoid and chemotherapy |
| [Arsenic trioxide](https://oncolabels.com/drugs/arsenic-trioxide) (Trisenox) | PML::RARA fusion (defines the disease) | + all-trans-retinoic acid (ATRA) | Consolidation | Acute promyelocytic leukaemia only; Newly diagnosed; low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl |
| [Arsenic trioxide](https://oncolabels.com/drugs/arsenic-trioxide) (Trisenox) | t(15;17) translocation and/or PML/RAR-alpha gene | Monotherapy | Consolidation | Acute promyelocytic leukaemia only; After previous treatment should have included a retinoid and chemotherapy; Relapsed/refractory |

## Label wording

- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, induction: “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)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, induction: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, consolidation: “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)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)
- **Arsenic trioxide** (Trisenox), Acute myeloid leukaemia, consolidation: “TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
• 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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/acute-myeloid-leukaemia/pml-rara