> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Genentech’s Gazyva for Follicular Lymphoma
- URL: https://www.fdaweb.com/fda-approves-genentechs-gazyva-for-follicular-lymphoma/
- Published: 2016-02-26T12:00:00.000Z
- Updated: 2026-09-15T02:39:00.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5134897

> FDA has approved a Genentech supplemental BLA 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)-containing regimen, or whose follicular lymphoma returned after such treatment. Follicular lymphoma is the most common slow-growing non-Hodgkin’s lymphoma (NHL), according to the company, and accounts for about 20% of NHL cases each year.  
>  
> Approval is based on data from the Phase 3 GADOLIN study, which showed that Gazyva plus bendamustine followed by Gazyva alone demonstrated a 52% reduction in the risk of disease worsening or death compared to bendamustine alone, as assessed by an independent review committee. The most common Grade 3-4 side effects of the Gazyva regimen were low white blood cell counts, infusion reactions and low platelet counts, Genentech says.  
>  
> Gazyva is also approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia.