EMEA Grants Orphan Drug Designation To CTI’s Pixantrone

The European Medicines Agency (EMEA) has granted Cell Therapeutics’ (CTI) Pixantrone, orphan drug designation for the treatment of diffuse large b-cell lymphoma (DLBCL).

CTI expects to file the Marketing Authorization Application (MAA) in Europe for approval of Pixantrone in mid-2010, and would be granted ten-year market exclusivity if it is approved.

In the US, the FDA’s 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 US and is in review for approval by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.

Craig Philips, president of CTI, said: “Orphan drug designation for Pixantrone in Europe demonstrates that there is clear unmet medical need for patients with DLBCL. We will continue to work with the EMEA to move our application forward in Europe expeditiously as we prepare for potential commercial launch of Pixantrone in the United States.”