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.

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.

This statement is based on a regulatory approval from the European Medicines Agency:

RISENOX is indicated 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.

Citation

Teva B.V. Trisenox (arsenic trioxide) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf. Revised May 2023. Accessed March 25, 2024.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2016-11-14	European Medicines Agency	Indication received approval from the European Commission.