Posted by Michael Wonder on 22 Jul 2017
CHMP recommends EU approval of Roche’s Gazyvaro for people with previously untreated advanced follicular lymphoma
21 July 2017 - Pivotal GALLIUM study demonstrated that Gazyvaro-based treatment helped people with previously untreated follicular lymphoma live significantly longer without disease progression compared to MabThera-based treatment.
Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro (obinutuzumab) in combination with chemotherapy, followed by Gazyvaro maintenance in people achieving a response, as a new treatment option for previously untreated advanced follicular lymphoma.
The CHMP’s recommendation is based on results from the phase III GALLIUM study. Follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin lymphoma, is considered incurable, and most people relapse repeatedly. Based on this positive CHMP recommendation, a final decision regarding the approval of Gazyvaro is expected from the European Commission in the near future.
