First-Line Gazyva GALLIUM Success Bolsters Roche's CD20 Franchise
Roche has caught investors off guard with the early announcement that its Phase III GALLIUM study of Gazyva in first-line follicular lymphoma has reached its primary endpoint of progression-free survival when pitted against the company's own standard-of-care treatment MabThera.
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Genentech’s next-generation anti-CD20 antibody Gazyva bested the Roche subsidiary’s original CD20-targeting therapy Rituxan in first-line follicular lymphoma – a result in the Phase III GALLIUM study that one oncologist viewed as “practice-changing.”
Sandoz has used data extrapolation to all the indications for Roche's MabThera in its marketing submission for biosimilar rituximab, just accepted for review by the European Medicines Agency.
Roche AG unit Genentech Inc. won the FDA's approval to market Gazyva (obinutuzumab) as a treatment for follicular lymphoma, the most common type of indolent non-Hodgkin's lymphoma (NHL), accounting for about one in five cases of the disease.