The U.S. Food and Drug Administration (FDA) granted its approval this week for TEVA Pharmaceutical’s new Leukemia treatment, TRISENOX® (arsenic trioxidec), according to a statement on the company’s website.
A medication administered by injection, TRISENOX® has been approved for use in combination with tretinoin for treatment of recently-diagnosed low-risk adults with acute promyelocytic leukemia (APL).
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.
Three months ago Teva announced the medication was to be granted priority by the FDA, with a decision expected in the first quarter of 2018.
“Today’s approval to expand the indication of TRISENOX® is a testament to Teva’s commitment to providing solutions to advance cancer care,” said Teva Oncology senior VP and general manager Paul Rittman.
“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).