Gazyvaro is an engineered monoclonal antibody proposed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. It is designed to attack and destroy targeted B-cells both directly and together with the body's immune system.
The approval was based on date from the phase III Gallium study, which showed advanced progression-free survival (PFS) over MabThera (rituximab)-based treatment, the current standard of care.
Gallium study demonstrated that Gazyvaro-based treatment decreased the risk of disease progression or death, as evaluated by investigator assessment, by 34%.
In 2014, Gazyvaro was approved in combination with chlorambucil by EU to treat previously untreated chronic lymphocytic leukaemia with comorbidities that make them unsuitable for full-dose fludarabine-based therapy.
Gallium is an open-label, multi-center and randomised two-arm study assessing the efficacy and safety of Gazyvaro plus chemotherapy followed by Gazyvaro alone for up to two years, as compared head-to-head against MabThera plus chemotherapy followed by MabThera alone for two years or until disease progression (whichever occurs first).
The study’s primary endpoint was investigator-assessed PFS in patients with follicular lymphoma, with secondary endpoints including PFS assessed by IRC, PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS), and safety.
Roche chief medical officer and global product development head Dr Sandra Horning said: “Every year an estimated 19,000 people in Europe are diagnosed with follicular lymphoma, which is considered to be incurable.
“We are pleased that with today’s approval of Gazyvaro, these patients now have an improved initial treatment option available to them.”