Servier has announced that its non-Hodgkin B-cell lymphoma drug, Pixuvri (pixantrone), has been granted the conversion of the conditional approval into standard marketing authorisation as a single agent.
The indication noted is for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.
The company also announced that to satisfy requirements of the conditional authorisation, a further Phase III clinical study, PIX306, was completed to provide additional efficacy data to confirm the benefit of the treatment in patients that had received prior treatment regimens containing rituximab.
While the superiority of the drug with rituximab compared to gemcitabine with rituximab was not met, both progression-free survival and overall survival results in patients with ≥ 2 prior treatment lines were similar, when indirectly compared to the Pixuvri treated population in the pivotal study PIX301.
There are currently “limited treatment options for multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma,” said Professor Pier Luigi Zinzani from the University of Bologna Institute of Hematology and Medical Oncology in Bologna, Italy.
He explained, “Pixuvri has demonstrated efficacy in late stage disease and the EC approval confirms Pixuvri as a treatment option for these patients.”
Patrick Therasse, head of Servier Research and Development Oncology noted how proud the company was, saying: “Pixuvri has been benefitting patients since its conditional approval in 2012 but today’s decision brings reassurance to patients and clinicians that this medicine remains a relevant treatment option in this indication.”