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# Genentech’s Gazyva OK’d for Advanced Follicular Lymphoma
- URL: https://www.fdaweb.com/genentechs-gazyva-okd-for-advanced-follicular-lymphoma/
- Published: 2017-11-16T12:00:00.000Z
- Updated: 2026-09-14T23:02:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140145

FDA has approved Genentech’s 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). Approval is based on results from the Phase 3 GALLIUM study, which showed superior progression-free survival for patients who received the Gazyva-based regimen compared with those who received a Rituxan (rituximab)-based regimen as an initial (first-line) therapy.

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells, according to the company. “It is thought to work by attacking targeted cells both directly and together with the body’s immune system,” it says. Adverse reactions include infusion reactions, severe skin and mouth reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy, a rare, serious brain infection that can lead to severe disability and death.