Posted by Michael Wonder on 10 Apr 2019
Pixuvri (pixantrone) receives positive CHMP opinion to convert conditional approval into standard marketing authorisation in patients with aggressive non-Hodgkin B-cell lymphoma
9 April 2019 - Servier today announced that the CHMP of the EMA has issued a positive opinion for Pixuvri (pixantrone) to convert its conditional approval into a standard marketing authorisation 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 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 authorisation for Pixuvri as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma. Conditional marketing authorisations 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.
