Trisenox (arsenic trioxide) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Cephalon, Inc. Trisenox (arsenic trioxide) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf. Revised September 2000. Accessed October 6, 2026.

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Regulatory approvals

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

Indication Statements
TRISENOX is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) PML::RARA Acute Promyelocytic Leukemia with PML::RARA Arsenic trioxide
FDA (1) t(15;17) Acute Promyelocytic Leukemia with PML::RARA Arsenic trioxide