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| CELG > SEC Filings for CELG > Form 8-K on 23-Dec-2008 | All Recent SEC Filings |
23-Dec-2008
Other Events
On December 23, 2008, Celgene International Sàrl announced that its cancer drug, VIDAZA (azacitidine), has been granted full marketing authorization by the European Commission for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:
• Intermediate-2 and high-risk MDS according to the IPSS, or
• Chronic myelomonocytic leukaemia (CMML) with 10-29 percent marrow blasts without myeloproliferative disorder, or
• AML with 20-30 percent blasts and multi-lineage dysplasia, according to WHO classification
The approval was based upon efficacy and safety data from clinical studies evaluating VIDAZA in MDS and RAEB-T patients within the AML category as defined by the WHO classification system. These pivotal efficacy and safety data were primarily provided from the VIDAZA survival trial (AZA-001), the largest, international randomized Phase III controlled study ever conducted in higher-risk MDS and WHO AML patients, demonstrating a clinically relevant increase in median survival of 9.4 months (24.4 vs. 15 months) as compared to conventional care regimens.
Attached hereto and incorporated herein by reference as Exhibit 99.1 is the Press Release announcing such information.
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