Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PML::RARA status confers therapeutic sensitivity to Arsenic trioxide in patients with APL with PML-RARA.
The European Medicines Agency (EMA) has authorized arsenic trioxide for induction of remission, and consolidation in adult patients with either newly diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL) (white blood cell count, <= 10 x 10^3 / ul) in combination with all-trans-retinoic acid (ATRA) or relapsed / refractory acute promyelocytic leukemia (APL) (previous treatment should have included a retinoid and chemotherapy). Both contexts should be characterized by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukemia / retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
This statement is based on a regulatory approval from the European Medicines Agency:
RISENOX is indicated for induction of remission, and consolidation in adult patients with either newly diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL) (white blood cell count, <= 10 x 10^3 / ul) in combination with all-trans-retinoic acid (ATRA) or relapsed / refractory acute promyelocytic leukemia (APL) (previous treatment should have included a retinoid and chemotherapy). Both contexts should be characterized by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukemia / retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.