Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PML::RARA status confers therapeutic sensitivity to Arsenic trioxide in patients with Acute Promyelocytic Leukemia 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 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.

This statement is based on a regulatory approval from the Health Service Executive:

Treatement of patients with relapsed or refractory APL after ATRA/chemotherapy

Citation

Trentinoin (ATRA) and Arsenic Trioxide (ATO) Induction Therapy, 2023, version number 4, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6962/356_v4_ATRA_-Arsenic_trioxide_Induction_Therapy.pdf

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2018-07-09	Health Service Executive	Indication approved for reimbursement.