FDA may accept revised pixantrone NDA filing

Seattle, USA-based Cell Therapeutics says that, following discussions with the Food and Drug Administration, it has decided to conduct a full analysis of the ongoing trial of its anticancer agent pixantrone rather than the planned interim analysis. The firm explained that the FDA had advised that an endpoint analysis demonstrating statistical significance could be acceptable as part of a New Drug Application submission, despite the fact that it was based on data from less than the 320 subjects originally sought.

The EXTEND trial, which is examining pixantrone in patients with aggressive non-Hodgkin's lymphoma, recruited patients who are sensitive to anthracycline treatment and had received two or more prior therapies. Those eligible were randomized to receive either pixantrone, or an established single-agent drug currently used in NHL. Endpoints include both complete and overall response rates, time-to- tumor progression as well as the overall survival rate. The program is expected to complete by the end of the year.

In addition, the firm said that the recently-reported RAPID trial showed that pixantrone cut the incidence of severe heart damage when compared with doxorubicin-based therapy.