The FDA has approved the use of arsenic trioxide (Trisenox, Teva) 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 is based on results from APL0406, a multicenter, randomized, open-label trial in which patients with newly diagnosed low-risk APL (white blood cell count at diagnosis