This article is more than 5 years old. Information may no longer be current.
FDA approves Trisenox plus tretinoin as first-line therapy for acute promyelocytic leukemia
Click Here to Manage Email Alerts
The FDA approved arsenic trioxide injection in combination with tretinoin for the treatment of patients with newly diagnosed low-risk acute promyelocytic leukemia and t(15;17) or PML/RAR-alpha gene expression.
Arsenic trioxide injection (Trisenox, Teva Pharmaceuticals) is also indicated for the induction of remission and consolidation for patients with acute promyelocytic leukemia who are refractory to, or relapsed from, retinoid and anthracycline chemotherapy.
The FDA based this approval on published scientific literature and a 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,” Paul Rittman, senior vice president and general manager of Teva Oncology, said in a press release. “This label expansion represents an important benefit as Trisenox is now an FDA-approved first-line treatment option for patients with acute promyelocytic leukemia.”
Arsenic trioxide injection previously received priority review designation.