Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	PML::RARA	Acute Promyelocytic Leukemia with PML::RARA	Arsenic trioxide

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.