Teva’s Trisenox approved for new APL indication in Europe

Teva has announced that its drug Trisenox has been approved in a new acute promyelocytic leukaemia (APL) indication by the European Commission.

The regulator has granted an extension of the drug's indication to include first-line use of Trisenox in combination with retinoic acid for patients with low to intermediate-risk acute promyelocytic leukaemia.

This marks the first time that European regulators have approved a treatment regimen for any form of acute leukaemia that is entirely chemotherapy-free, offering a new approach to fighting this rare and aggressive type of cancer.

Trisenox, in combination with retinoic acid, has shown a 99 percent overall survival rate with almost no relapses after more than four years of median follow-up.

Dr Rob Koremans, president and chief executive officer for Teva's global specialty medicines division, 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."

In Europe, approximately 1,500 to 2,000 people are diagnosed with APL each year, with the disease killing within hours or days if left untreated.

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