Pixantrone, an investigational drug to treat diffuse large B-cell lymphoma (DLBCL), has been granted Orphan Drug status from European Medicines Agency (EMEA), Cell Therapeutics announced in a press release.
Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents.
Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later.
As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns.
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.
Pixantrone’s New Drug Application (NDA) the treatment of relapsed/refractory aggressive non-Hodgkin’s lymphoma (NHL) will be reviewed by the US Food & Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) on February 10, 2010.
Pixantrone has received a fast track designation from US FDA as well and the product has a prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
Orphan drug designation is granted in Europe for medical treatments and drugs intended to treat life-threatening or chronically debilitating conditions.
Orphan drug designation enables pixantrone to get regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and assistance with clinical trial design.
“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,” stated Craig W. Philips, President of CTI.
Diffuse large B-cell lymphoma (DLBCL) accounts for about 80% of aggressive non-Hodgkin’s lymphoma.
Headquartered in Seattle, CTI is a biopharmaceutical company developing an integrated portfolio of oncology products aimed at making cancer more treatable.