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/2018/021248s015lbledt.pdf. Revised January 2018. 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 in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) 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