CTIC 第二贴。

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European Medicines Agency Grants Cell Therapeutics, Inc. (CTI)Orphan Drug Designation for Pixantrone in Diffuse Large B-Cell Lymphoma
1:30am EST

Cell Therapeutics, Inc. (CTI) announced that the European Medicines Agency (EMEA) has granted pixantrone orphan drug designation for the treatment of DLBCL which accounts for about 80% of aggressive non-Hodgkin's lymphoma. CTI expects to file the Marketing Authorization Application (MAA) in Europe for approval of pixantrone in mid-2010 and would be granted 10 year market exclusivity if it is approved. In the U.S., the Food & Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) plans to review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) on February 10, 2010. Pixantrone is a fast track designated product in the U.S. and is in review for approval by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.

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