Trisenox (arsenic trioxide) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies