Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) PML::RARA Acute Promyelocytic Leukemia with PML::RARA Arsenic trioxide
FDA (2) t(15;17) Acute Promyelocytic Leukemia with PML::RARA Arsenic trioxide

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.