France’s Servier has won full European approval for Pixuvri (pixantrone) for adults with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.
The European Medicines Agency initially granted conditional approval based on the pivotal PIX301 trial, and full approval was granted based on the confirmatory PIX306 Phase III study.
Research head Patrick Therasse said: “Pixuvri has been benefiting 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.”
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