FDA Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma

On November 16, Genentech announced that the U.S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III, or IV). Follicular lymphoma, the most common indolent form of non-Hodgkin lymphoma (NHL), is incurable and becomes harder to treat each time it returns.

The approval is based on results from the phase III GALLIUM study, which showed superior progression-free survival for patients who received this obinutuzumab-based regimen compared with those who received a rituximab (Rituxan)-based regimen as first-line therapy.

Obinutuzumab is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.

Clinical Trial Results

The GALLIUM study is a global phase III open-label, multicenter, randomized two-arm study examining the efficacy and safety of obinutuzumab plus chemotherapy followed by obinutuzumab alone for up to 2 years, as compared head-to-head against rituximab plus chemotherapy followed by rituximab alone for up to 2 years. Chemotherapies were selected by each participating study site prior to beginning enrollment. The study included 1,385 patients with previously untreated NHL, of whom 1,202 patients had advanced follicular lymphoma.

The obinutuzumab-based regimen significantly reduced the risk of disease worsening or death compared to a rituximab-based regimen by 28% (progression-free survival as assessed by independent review committee; hazard ratio = 0.72; 95% confidence interval = 0.56–0.93; P = .0118). The most common grade 3-5 side effects (occurring in at least 5% of patients) observed more frequently in the obinutuzumab arm were low white blood cell count, infusion reactions, low white blood cell count with fever, and low platelet count. The most common side effects (occurring in at least 20% of patients) observed at least 2% more frequently in the obinutuzumab arm included infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea.

Obinutuzumab’s supplemental Biologics License Application based on the GALLIUM data was granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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