(Reuters) – Cell Therapeutics Inc said European health regulators approved its cancer drug on the condition that the company complete a post-marketing study to confirm its clinical benefit.
Pixuvri is designed as a treatment for relapsed or refractory aggressive non-Hodgkin’s lymphoma in patients who failed two or more lines of prior therapy.
Cell Therapeutics expects to market the drug, Pixuvri, also known as pixantrone, in the 27 member states of the European Union as well as in Iceland, Liechtenstein and Norway in the second half of 2012.
A conditional marketing authorization is granted in the European Union for medical products that treat life-threatening diseases. This authorization is renewable annually.
In January, the company withdrew marketing application in the United States saying it needed more time to prepare for the review of the drug.