Genentech announced that the Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva monotherapy in responders, for patients with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). 

The FDA approval was supported by data from the Phase 3 GALLIUM study (n=1,385) that evaluated the safety and efficacy of Gazyva + chemotherapy followed by Gazyva alone for up to 2 years, compared to Rituxan (rituximab) + chemotherapy followed by Rituxan alone for up to 2 years; the chemotherapy (CHOP, CVP or bendamustine) regimen was chosen by each study site prior to study enrollment. Of the total patients with previously untreated non-Hodgkin’s lymphoma (NHL), 1,202 had advanced follicular lymphoma (stage II bulky, III or IV). 

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The data showed superior progression-free survival (PFS) in patients treated with the Gazyva-based regimen vs. patients treated with the Rituxan-based regimen. The Gazyva-based regimen significantly reduced the risk of disease worsening or death by 28% vs. the Rituxan-based regimen (hazard ratio [HR] 0.72, 95% CI: 0.56–0.93; P=0.0118). Overall response rate (ORR), a secondary endpoint, was seen in 91% of the Gazyva cohort vs. 88% of the Rituxan cohort. 

The most common adverse effects (≥20% occurrence) seen more frequently in the Gazyva arm were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea.

Gazyva, a CD20-directed cytolytic monoclonal antibody, is already indicated in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL); and in combination with bendamustine followed by Gazyva monotherapy, for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. 

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