Glivec receives CHMP OK for DFSP and Ph+ ALL
Swiss drug major Novartis reports that the Committee for Medicinal Products for Human Use of the European Medicines Agency has expressed a positive opinion regarding the use of Glivec (imatinib), the firm's anticancer agent, in the treatment of solid tumor dermatofibrosarcoma protuberans (DFSP) and Philadelphia chromosome-positive acute lymphocytic leukemia.
The CHMP's conclusion is based on data from a trial of the product that demonstrated its efficacy in the treatment of both conditions, mediated through its interaction with tyrosine kinases that are involved in tumor proliferation.
The drug, which is currently approved in over 90 countries for use in all phases of Philadelphia chromosome positive chronic myeloid leukemia, is also under CHMP review as a treatment for the following three conditions: myeloproliferative disorders; hypereosinophilic syndrome; and systemic mastocytosis.
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