Teva’s Trisenox approved in Europe for first line treatment of APL

APL is a rare type of blood cancer that can kill within hours or days if it is not treated.  About 1,500 to 2,000 people in Europe are diagnosed with APL every year.

Trisenox (arsenic trioxide) was initially approved in Europe in 2002 to treat patients with relapsed or refractory APL and characterized by the presence of the t(15;17) translocation or the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptoralpha gene.

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion backing approval for the indication extension.

Teva said the latest decision was solely based on published academic data endorsing the benefit of Trisenox as first chemotherapy-free treatment for APL.

In the APL0406 Intergroup GIMEMA-AMLSG-SAL study, Trisenox, in combination with retinoic acid, has demonstrated a 99% overall survival rate with almost no relapses after more than four years of median follow-up.

Teva Global Specialty Medicines president & CEO Rob Koremans said: “We’re very pleased by this decision of the European Commission, and we look forward to offering a chemotherapy-free treatment option for all newly diagnosed APL patients.”

The US Food and Drug Administration granted Trisenox marketing authorization in 2000.

CTI BioPharma originally developed Trisenox, which was acquired by Cephalon in 2005 for $70m and milestone payments. Teva then purchased Cephalon in 2011 for $6.8bn.

Image: Teva in Markham, Ontario. Photo: courtesy of Raysonho @ Open Grid Scheduler / Grid Engine.