Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PML::RARA status confers therapeutic sensitivity to Arsenic trioxide in patients with APL with PML-RARA.
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.
This statement is based on a regulatory approval from the Health Service Executive:
Treatement of patients with newly diagnosed low to intermediate risk Acute Promyelocytic Leukaemia (APL) (defined as WCC count <= 10x10^9/L)