Novartis AG (NOVN.EB) said Monday that its drug Tasigna secured European Union approval for first and second-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, or Ph+ CML-CP, in children.
It means Tasigna is the only second-generation tyrosine kinase inhibitor currently approved in the EU for this treatment in children, Novartis said. The approval follows a positive opinion issued on Sep. 14 by the European Medicines Agency's Committee for Medicinal Products for Human Use.
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Chronic Myeloid Leukemia, or CML, is responsible for approximately 10% to 15% of all adult cases of Leukemia, with an incidence of one to two cases per 100,000 a year, Novartis said. Almost all patients with CML have an abnormality known as the Philadelphia chromosone it added.
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(END) Dow Jones Newswires
November 20, 2017 02:18 ET (07:18 GMT)