Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PML::RARA status confers therapeutic sensitivity to Arsenic trioxide in patients with Acute Promyelocytic Leukemia with PML::RARA.

The U.S. Food and Drug Administration granted approval to arsenic trioxide in combination with tretinoin for the treatment of adult patients 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.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

Citation

Cephalon, Inc. Trisenox (arsenic trioxide) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021248s019lbl.pdf. Revised October 2020. Accessed October 30, 2024. 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.

Contributions

Date	Contributor	Description
2025-06-26	Van Allen lab	Resolving statements mapped to incorrect propositions
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-01-12	Food and Drug Administration	Indication received traditional approval.