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Genentech’s Gazyva Gains NHL Indication

February 29, 2016

Phase III results show PFS in previously treated Follicular Lymphoma

Genentech, a member of the Roche Group, received approval from the FDA for Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab) regimen. Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin’s lymphoma (NHL) and accounts for approximately one in five cases of NHL.

The approval is based Phase III results showing that Gazyva plus bendamustine followed by Gazyva alone demonstrated a 52% reduction in the risk of disease worsening or death (progression-free survival, PFS), compared to bendamustine alone, as assessed by an independent review committee (IRC). The supplemental Biologics License Application based on these data was granted Priority Review, a designation granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
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