Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

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
Sensitivity (+)	PML::RARA	APL with PML-RARA	Arsenic trioxide