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Novartis Tasigna(R) (nilotinib) Trial Shows Superior Results to Glivec(R) (imatinib) in Newly Diagnosed, Chronic Phase Chronic Myeloid Leukaemia
Date:12/8/2009

positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) and the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.

Furthermore, imatinib is approved for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy, adult patients with relapsed or refractory Ph+ ALL as monotherapy, adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR alpha rearrangement and the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

    For imatinib summary of product characteristics, please see:
    http://emc.medicines.org.uk/document.aspx?documentId=15014

    References

    (1) Saglio G, Kim DW, Issaragrisil S, Philipp le Coutre, et al.
        Nilotinib Demonstrates Superior Efficacy Compared with Imatinib in
        Patients with Newly Diagnosed Chronic Myeloid Leukaemia in Chronic
        Phase: Results from the International Randomized Phase III ENESTnd
        Trial. American Society of Hematology 2009. Abstract number LBA-1

    (2) NICE Guidance on the use of imatinib for chronic myeloid leukaemia
        - Technology Appraisal 70. October 2003

    (3) Faderl S; Talpaz M; Estrov Z; O'Brien S; Kurzrock R; Kantarjian HM.
        The biology of chronic myeloid leukemia. N Engl J Med. 341:164-72,
        1999.

    (4) National Cancer Institute. Ge
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