The European Medicines Agency (EMEA) has granted orphan-drug designation to pixantrone, Cell Therapeutics’ (CTI) treatment for diffuse large b-cell lymphoma (DLBCL).
The drug would be of use to 80% of patients with aggressive non-Hodgkin’s lymphoma, and approval would mean a 10-year marketing deal. CTI will reportedly seek a marketing authorisation application (MAA) in mid-2010.
Orphan-drug designation covers life-threatening or chronically debilitating conditions, and includes benefits such as regulatory assistance and help with clinical trial design.
Says CTI president Craig Philips: “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.”
Copyright Press Association 2009