Genentech has announced that the Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) plus bendamustine chemotherapy, followed by Gazyva alone, for follicular lymphoma patients who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.
Gazyva is a monoclonal antibody designed to attach to CD20, a protein found only on B-cells, and attack targeted cells both directly and together with the body’s immune system. Gazyva was previously approved for treatment of patients with previously untreated chronic lymphocytic leukemia, in combination with chlorambucil.
The new approval is based on results from a 413 patient, Phase III trial (GADOLIN) study, which showed that Gazyva plus bendamustine followed by Gazyva alone was associated with a 52% reduction (HR=0.48, 95 percent CI 0.34-0.68, p<0.0001) in the risk of disease worsening or death (progression-free survival, PFS) compared to bendamustine alone.
The supplemental Biologics License Application (BLA) based on these data was granted Priority Review, indicating that the drug has the potential to provide significant improvements in the treatment of the diseas
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