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news.Pharmion has reported that the European Medicines Agency has issued a positive opinion to recommend approval of Thalidomide Pharmion for use in combination with melphalan and prednisone as first line treatment for patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose chemotherapy.
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The marketing authorization application (MAA) for Thalidomide Pharmion was submitted to the European Medicines Agency (EMEA) in January 2007. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) reviewed the application, and its positive opinion will be forwarded to the European Commission (EC). Once ratified by the EC, a single marketing authorization would be granted to Pharmion to market Thalidomide Pharmion for first line multiple myeloma in the 27 member states of the European Union (EU) as well as Norway and Iceland.
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.