CHMP recommends approval of Pixuvri in non-Hodgkin B-cell lymphoma

Servier announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Pixuvri (pixantrone) to convert its conditional approval into a standard marketing authorization as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma. The CHMP’s opinion will now be sent to the European Commission (EC) for the adoption of the decision.

In 2012, in recognition of the lack of standard of care and the poor prognosis for patients with aggressive non-Hodgkin B-cell lymphoma, the EMA gave a conditional marketing authorization for Pixuvri as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma. Conditional marketing authorizations are granted in the EU to speed access to products that address unmet medical needs and where availability would result in a significant public health benefit.

The positive opinion from the CHMP is based on data from the global clinical development of Pixuvri. The pivotal study, PIX301 was an open-label, randomized, Phase III study comparing 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 (p=0.021).