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).
Subtype
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| PML::RARA fusion4 | ||||
Trisenox | 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 |
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 |
Trisenox | Defines the disease | + all-trans-retinoic acid (ATRA) | Consol. | Acute promyelocytic leukaemia only; Newly diagnosed; low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl |
Trisenox | t(15;17) translocation and/or PML/RAR-alpha gene | Monotherapy | Consol. | Acute promyelocytic leukaemia only; After previous treatment should have included a retinoid and chemotherapy; Relapsed/refractory |
2 approvals for AML need no biomarker and apply whatever the result. All approvals for AML
See also
Label wording4
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Arsenic trioxide (Trisenox)
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)
- Arsenic trioxide (Trisenox)
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.
- Arsenic trioxide (Trisenox)
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)
- Arsenic trioxide (Trisenox)
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.