Novartis Glivec approved by EC for Ph+ ALL and DFSP

24 September 2006

Swiss drug major Novartis says it has received additional European Union approvals for its anticancer agent Glivec (imatinib). The product has been approved for use in the treatment of patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia, both in combination with chemotherapy and as a monotherapy in patients with relapsed or refractory forms of the disease. In addition, the drug has been passed by regulators as a therapy for adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP), who are not eligible for surgery. The firm added that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use is currently assessing the agent as a treatment for hypereosinophilic syndrome, systemioc mastocytosis and myelodysplastic diseases.

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