Yesterday, Cell Therapeutics (CTIC) released encouraging data from the 18-month follow-up clinical trial of pixantrone for the treatment of patients with advanced, relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL).

The original trial compared pixantrone with standard chemotherapy; the results of which were reported last November. The company completed filing its rolling New Drug Application (NDA) in June this year and has been assigned a Prescription Drug User Fee Act (PDUFA) date of Apr 23, 2010.

The follow-up trial conducted over a period of 18 months found improved results for patients on pixantrone compared to the control group. Based on the parameters of complete response (25.7% vs. 7.1% in control group), overall response rate (40% vs. 14.3%) and progression free survival (5.6 months vs. 2.6 months), the pixantrone data were better compared to both the control group and its own original trial data. Cell Therapeutics plans to submit the updated data to the FDA shortly.

Meanwhile, Cell Therapeutics submitted a Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMEA). This is part of the filing process for pixantrone approval in the treatment of children in Europe. It includes the course of action to be undertaken by the company in order to broaden its use for pediatric patients.

Pixantrone, on approval, will have to face tough competition from several established products. One of the top-selling drugs for the treatment of NHL is Rituxan, co-promoted by Biogen Idec (BIIB) and Genentech (a part of Roche) in the US. Biogen recorded sales of $1.13 billion from Rituxan in 2008, an increase of 18% over 2007. Competition is quite tough in this therapeutic area with the presence of Genzyme’s (GENZ) Campath, Millennium’s (a part of Takeda now) Velcade and Cephalon‘s (CEPH) Treanda, among others.

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