FDA Approves First-Line Injection for APL

01/16/18

The US Food and Drug Administration (FDA) has approved an injection in combination with an established oral therapy for the treatment of acute promyelocytic leukemia.

Arsenic trioxide (Trisenox, Teva Pharmaceuticals) is now approved in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose disease is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The injection was previously indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose disease is characterized by the presence of t(15;17) translocation or PML/RAR-alpha gene expression.

FDA approval came following a Priority Review based 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, in a press release (January 15, 2018). “This label expansion represents an important benefit as Trisenox is now an FDA-approved first line treatment option for patients with acute promyelocytic leukemia.”

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

Arsenic trioxide includes a Boxed Warning regarding differentiation syndrome and cardiac conduction abnormalities.—Zachary Bessette