Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) 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 and a review of Teva’s global safety database for arsenic trioxide.
“Today’s approval to expand the indication of TRISENOX is a testament to Teva’s commitment to providing solutions to advance cancer care,” said Paul Rittman, Senior Vice President and General Manager, Teva Oncology. “This label expansion represents an important benefit as TRISENOX is now an FDA-approved first line treatment option for patients with acute promyelocytic leukemia.”
The new indication reinforces the current practice guidelines by the National Comprehensive Cancer Network® (NCCN).
