Teva Pharmaceutical Industries Ltd. TEVA announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expanding Trisenox's label in the EU. The company is looking to get Trisenox approved in combination with retinoic acid for the treatment of low to intermediate risk acute promyelocytic leukemia (APL).
The positive CHMP opinion was based on the existing academic data on the benefit of this chemotherapy-free treatment regimen. With the CHMP issuing a positive opinion, chances of gaining EU approval for expanded use appear high. A decision should be out by the end of the year.
Trisenox's approval for expanded use would make it the first time for a form of acute leukemia to be effectively treated with a regimen that is completely chemotherapy-free.
Note that Trisenox is currently approved for the second-line treatment of APL patients who have not responded to treatment with retinoids and chemotherapy, or when their disease has returned after this type of treatment.
Per the company's press release, APL is a rare and aggressive type of acute leukemia with around 1,500 to 2,000 diagnosed with the disease annually in Europe.
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