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First-Line Gazyva GALLIUM Success Bolsters Roche's CD20 Franchise

Executive Summary

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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Gazyva’s GALLIUM Could Be ‘Practice-Changing’ For Follicular Lymphoma

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 Extrapolates Biosimilar Rituximab Data For EU Filing

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.

New Market For Genentech's Gazyva: Follicular Lymphoma

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.





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