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Phase 3 Trial Shows Denosumab Delayed Skeletal Related Events in Advanced Cancer Patients With Bone Metastases
Date:9/21/2009

r effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

ZOMETA is a registered trademark of Novartis Oncology.

*Editors Note: The FDA has provisionally approved the trade name Prolia(TM) for the proposed indications of treatment and prevention of osteoporosis in postmenopausal women, and treatment and prevention of bone loss in patients undergoing hormone ablation for non-metastatic prostate or breast cancer, for which denosumab is administered twice yearly subcutaneously at a 60 mg dose. The Prolia(TM) trade name is only for these indications and may not apply for other indications of denosumab.

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    1. Cleeland CS, et al. Pain and its treatment in outpatients with
    metastatic cancer. N Engl J Med. 1994: 330:592-596.
    2. Capanna R, Coia LR, Coleman R. et al. eds. Textbook of Bone Metastases.
    Hoboken, NJ: Edition: John Wiley and Sons; 2005:105.
    3. Mundy GR. Metastasis to bone: causes, consequences and therapeutic
    opportunities. Nat Rev Cancer. 2002 Aug;2(8):584-93.
    4. Schulman K and Kohles J. Cancer. 2007;109:2334-2342
    5. GVD/Barber ISPOR 2008 Poster; Schulman 2007; Delea et al. 2006


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