Regulatory approval
Published by the European Medicines Agency.
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 is written in the approval document as:
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PML::RARA | APL with PML-RARA | Arsenic trioxide |