FDA approves Roche ’s Gazyva for previously untreated advanced follicular lymphoma

Roche announced today that the US Food and Drug Administration (FDA) approved Gazyva ® (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). The approval is based on results from the phase III GALLIUM study, which showed superior progression-fre e survival (PFS) for patients who received this Gazyva-based regimen compared with those who received a Rituxan® (rituximab)-based regimen as an initial (first-line) therapy. Follicular lymphoma, the most common slow-growing (indolent) form of non-Hodgkin lymphoma (NHL), is incurable and becomes ha rder to treat each time it returns.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news