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Thalidomide Pharmion(R) Receives Positive Opinion for Treatment of First-line Multiple Myeloma from European Medicines Agency
Date:1/24/2008

g and complex process and I would like to thank all of the participants in the dialogue that has led to this recommendation by the EMEA, which include European thalidomide groups, patient organizations, the hematology community and the employees of Pharmion who made this happen. We have been and will remain committed to managing Thalidomide with the respect that its history requires."

The Marketing Authorization Application reviewed by the EMEA is based upon a clinical data package comprised of studies of nearly 1400 patients in total, including the Intergroupe Francophone du Myelome (IFM) 99-06 survival study. The three-arm study conducted by IFM demonstrated the superiority of melphalan/prednisone plus Thalidomide (MPT) over standard therapy of melphalan/prednisone (MP) or a combination of chemotherapies (vincristine/adriamycin/dexamethasone (VAD)) followed by melphalan and transplantation (MEL 100) in the treatment of newly diagnosed multiple myeloma patients, aged 65 to 75 who were ineligible for intensive bone marrow transplantation. A total of 447 patients were randomized to one of the three treatment arms. At final analysis, the overall median survival in the MPT arm was 51.6 months, compared to 33.2 and 38.3 months, respectively, for the MP and MEL 100 arms. The hazard ratios were 0.59 and 0.69, respectively. Thalidomide treatment was generally well-tolerated by the majority of patients. The most frequently reported adverse events associated with MPT included neutropenia, somnolence and constipation. The Thalidomide combination was also associated with a 5-10% greater risk of Grade 3 and 4 venous thromboembolism and peripheral neuropathy.

"Our study results demonstrate the profound impact on overall survival that the addition of Thalidomide to the standard of care can provide to patients with untreated multiple myeloma," said Professor Philippe Moreau, Professor of Clinical Hematology at Nantes Faculty of Medicine and Chairman of the Intergroup
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