Therapeutic Response

PML::RARA status confers therapeutic sensitivity to Arsenic trioxide in patients with APL with PML-RARA.

Statements

Source and description
Trisenox (arsenic trioxide) [product information]. EMA. The European Medicines Agency (EMA) has authorized arsenic trioxide for induction of remission, and consolidation in adult patients with either newly diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL) (white blood cell count, <= 10 x 10^3 / ul) in combination with all-trans-retinoic acid (ATRA) or relapsed / refractory acute promyelocytic leukemia (APL) (previous treatment should have included a retinoid and chemotherapy). Both contexts should be characterized by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukemia / retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
Trisenox (arsenic trioxide) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to arsenic trioxide in combination with tretinoin for the treatment of adult patients with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Trisenox (arsenic trioxide) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to arsenic trioxide for the induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Trentinoin (ATRA) and Arsenic Trioxide (ATO) Induction Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved tretinoin (ATRA) with arsenic trioxide (ATO) for reimbursement as a treatment option for the treatment of patients with newly diagnosed low to intermediate risk Acute Promyelocytic Leukaemia (APL) (defined as WCC <= 10x10^9L). This regimen contains the eligibility criteria of a clinical diagnosis of APL and subsequently confirmed to have PML::RARA rearrangements by a valid test method.
Trentinoin (ATRA) and Arsenic Trioxide (ATO) Induction Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved tretinoin (ATRA) with arsenic trioxide (ATO) for reimbursement as a treatment option for the treatment of adult patients with relapsed or refractory Acute Promyelocytic Leukaemia (APL) after ATRA/chemotherapy. This regimen contains the eligibility criteria of a clinical diagnosis of APL and subsequently confirmed to have PML::RARA rearrangements by a valid test method.