PML::RARA
4 EU-approved indications of 1 drug need a PML::RARA result, in 1 tumour type, most of them in acute myeloid leukaemia.
Approved indications4
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Acute myeloid leukaemia4 | ||||
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 |
PML::RARA by tumour
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.