FDA approves Gazyva® (obinutuzumab) for patients with previously untreated advanced FL

On 16^th November 2017, the U.S. Food and Drug Administration (FDA) approved Gazyva^® (obinutuzumab) for the treatment of adults with previously untreated stage II bulky, III, or IV follicular lymphoma (FL), in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission.

This approval was based on the results of a multicenter, open-label, randomized phase 3 trial (GALLIUM) that was previously reported by Lymphoma Hub on December 12, 2016. The primary results of the study were presented at the American Society of Hematology (ASH) 2016 annual meeting that showed clinically significant improvement in the progression-free survival (PFS) of patients being treated with an obinutuzumab-based regimen compared to rituximab-based (PFS: rituximab = 73.3%, obinutuzumab = 80.0%, HR = 0.66 (p=0.0012)).

In an interview with Lymphoma Hub, Sonali Smith provided insight as to whether the GALLIUM study results would change current practice in first-line FL patients. She said that there will be "ongoing debate as to whether or not this should become the new standard of care." She also noted that since the improvement in PFS was modest and that there was no difference in overall survival, "we will continue to debate the value of these two monoclonal antibodies," and that "the statistically significant improvement will probably change practice for many physicians."

Full prescribing information can be found here.