Posted by Michael Wonder on 14 Sep 2017
Teva receives FDA priority review for first line use of Trisenox (arsenic trioxide) in patients with low to intermediate risk acute promyelocytic leukaemia
12 September 2017 - Teva Pharmaceutical Industries announced today the U.S. FDA has accepted for review the company’s supplemental new drug application for the use of Trisenox (arsenic trioxide) injection in combination with all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with newly diagnosed low or intermediate risk acute promyelocytic leukemia (APL) whose APL is characterised by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
The FDA has accepted the application for priority review with regulatory action expected in the first quarter of 2018. FDA grants priority review to applications for drugs or biologics intended to treat serious conditions and address unmet medical needs. The filing includes data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide.
