General AML

Trisenox® granted EMA approval for first line treatment in APL patients

Arsenic trioxide (Trisenox®) has been granted approval from the European Commission (EC) for an indication extension in Acute Promyelocytic Leukemia (APL). The decision made by the EC follows a positive recommendation by the EMA CHMP, obtained on October 13th 2016.

APL is a rare and aggressive form of Acute Myeloid Leukemia, which can kill within hours or days, if left untreated. However, the GIMEMA trial (NCT00482833), has shown that at a median follow-up of more than 4 years  (50 months), Trisenox® in combination with all trans retinoic acid (ATRA) was able to reach 99% overall survival rate with almost no relapse in APL patients.  The full indication is as follows:

“Trisenox® is indicated for induction of remission, and consolidation in adult patients with newly diagnosed low-to-intermediate risk Acute Promyelocytic Leukaemia (APL) (white blood cell count, ≤ 10 x 103/µl) in combination with all‑trans‑retinoic acid (ATRA)

The combination of Trisenox® and all trans retinoic acid is the first time APL patients can be effectively treated with a regimen that is entirely chemotherapy-free thus marking an important advancement for treatment for APL patients in Europe.