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| |  Australian Agency Approves Thalidomide for the Treatment of Newly Diagnosed Multiple Myeloma BOUDRY, Switzerland -- April 7, 2008 -- The Australian Therapeutic Goods Administration (TGA) has approved a supplemental filing granting thalidomide pharmion marketing approval for use in combination with melphalan and prednisone for patients with untreated multiple myeloma or ineligible for high-dose chemotherapy. Additionally, thalidomide pharmion (Thalomid) was granted marketing approval in combination with dexamethasone for induction therapy prior to high-dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma. This marketing approval represents the first oral cancer therapy ever registered for patients newly diagnosed with multiple myeloma in Australia. Thalidomide pharmion was previously approved by the TGA in 2003 as a treatment for patients with multiple myeloma after failure of standard therapies. In January 2008, the TGA granted full marketing approval for the oral cancer therapy lenalidomide (Revlimid) for use in combination with dexamethasone as a treatment for patients with multiple myeloma whose disease has progressed after one therapy. "The TGA approval of thalidomide pharmion for newly diagnosed myeloma patients offers additional options in this critical disease area," said Aart Brouwer, President, Celgene International. The US Food and Drug Administration approved thalidomide on May 25, 2006, as an oral treatment in combination with dexamethasone for patients newly diagnosed with multiple myeloma.
SOURCE: Celgene International Sarl
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