Pixantrone lands orphan drug status in Europe
The European Medicines Agency has granted orphan drug status to Cell Therapeutics' pixantrone for the treatment of diffuse large B-cell lymphoma (DLBCL), allowing the company to move ahead with a Marketing Authorization Application (MAA) by the middle of the year.
In the US, Cell Therapeutics has submitted a New Drug Application (NDA) to the FDA for pixantrone to treat relapsed/refractory aggressive Non-Hodgkin's lymphoma (NHL), which will be reviewed by the FDA's Oncologic Drugs Advisory Committee (ODAC) in February 2010. Currently fast-tracked, pixantrone's FDA status will be determined in late April 2010.
- Source: Cell Therapeutics.
- Read about Phase II and Phase III clinical studies of pixantrone here.
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