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New FDA Approval for Genentech's GAZYVA®

On November 16, 2017, GAZYVA® (obinutuzumab), in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma (FL).

The FDA approval letter can be found at https://www.genentech-access.com/gazyva.html

The full Prescribing Information for GAZYVA can be found at https://www.gene.com/download/pdf/gazyva_prescribing.pdf.