Arsenic trioxide

Arsenic trioxide (Trisenox, Teva B.V.) has 4 EU-approved indications in 1 tumour type. Each needs a biomarker result: PML::RARA (4).
Approved indications of Arsenic trioxide
Biomarker requirementRegimenSettingConditions
Acute myeloid leukaemia4
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
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
PML::RARA fusion (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
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
Full text of section 4.1 (therapeutic indications)

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 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.

Label history

40 changes to the Trisenox label since 2002, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes