Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that t(15;17) status confers therapeutic sensitivity to Arsenic trioxide in patients with APL with PML-RARA.
The U.S. Food and Drug Administration granted approval to arsenic trioxide in combination with tretinoin for the treatment of adult patients 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.
This statement is based on a regulatory approval from the Food and Drug Administration:
TRISENOX is an arsenical 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 APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.