Posted by Michael Wonder on 24 Sep 2017
Roche receives EU approval of Gazyvaro for people with previously untreated advanced follicular lymphoma
22 September 2017 - Approval is based on phase III GALLIUM study results, which showed superior progression-free survival for Gazyva/Gazyvaro compared to MabThera/Rituxan.
Roche announced today that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chemotherapy, followed by Gazyvaro maintenance in people achieving a response, as a new treatment for previously untreated advanced follicular lymphoma.
The approval is based on results from the GALLIUM study, the first phase III study in previously untreated follicular lymphoma to show superior progression-free survival over MabThera (rituximab)-based treatment, the current standard of care.
