FDA grants priority review for Genentech’s Gazyva in previously untreated follicular lymphoma

Genentech

27 August 2017 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental biologics license application and granted priority review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. 

Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterised by cycles of remission and relapse.

The application is based on results of the GALLIUM study, which is the first Phase III study in previously untreated follicular lymphoma to show superior progression-free survival over Rituxan (rituximab)-based treatment, the current standard of care.

Read Genentech press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Priority review