Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia Approved by the FDA

On January 15, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the 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.

The approval was based on a Priority Review by the FDA on data from published scientific literature, as well as a review of Teva’s global safety database for arsenic trioxide.

“This label expansion represents an important benefit as [arsenic trioxide] is now an FDA-approved first-line treatment option for patients with acute promyelocytic leukemia,” said Paul Rittman, Senior Vice President and General Manager, Teva Oncology.

The new indication reinforces the current practice guidelines by the National Comprehensive Cancer Network®.

To see the full prescribing information for this treatment, visit

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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