The European Commission (EC) has converted conditional approval of Pixuvri into a standard marketing authorisation in patients with aggressive non-Hodgkin B-cell lymphoma, French pharma Servier has announced.
The approval is based on data from the global clinical development of Pixuvri (pixantrone).
“There are limited treatment options for multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma,” said Prof Pier Luigi Zinzani from the University of Bologna Institute of Haematology and Medical Oncology in Bologna, Italy.
“Pixuvri has demonstrated efficacy in late stage disease and the EC approval confirms Pixuvri as a treatment option for these patients.”
The pivotal Phase III study, PIX301 compared Pixuvri monotherapy with physician’s choice of treatment in 140 patients with relapsed or refractory aggressive non-Hodgkin lymphoma, 50% of whom had been previously treated with rituximab.
Pixuvri was shown to be beneficial in these patients: 20% of patients responded completely to Pixuvri compared with 5.7% of patients receiving other agents.
To satisfy requirements of the conditional authorization, a further Phase III clinical study, PIX306, was completed to provide additional efficacy data to confirm the benefit of Pixuvri in patients that had received prior treatment regimens containing rituximab.