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FDA approves Gazyva for treatment-naive advanced follicular lymphoma
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The FDA approved use of obinutuzumab as part of a therapeutic regimen for patients with treatment-naive advanced follicular lymphoma, according to the agent’s manufacturer.
Obinutuzumab (Gazyva, Genentech/Roche) is an engineered monoclonal antibody designed to attach to CD20.
The approval — which applies to patients with stage II bulky, stage III or stage IV disease — allows the use of obinutuzumab (Gazyva, Genentech/Roche) in combination with chemotherapy, followed by obinutuzumab monotherapy for those who respond to the initial combination regimen.
The FDA based the approval on results from the randomized phase 3 GALLIUM study, which included 1,385 patients with previously untreated non-Hodgkin lymphoma. Most patients (n = 1,202) had advanced follicular lymphoma.
Researchers assigned 601 patients to obinutuzumab plus chemotherapy followed by obinutuzumab alone for up to 2 years. The other 601 patients received rituximab (Rituxan; Genentech, Biogen) plus chemotherapy followed by rituximab alone for 2 years.
PFS served as the primary endpoint. Median follow-up was 38 months.
Median PFS had not been reached in either group. However, as HemOnc Today previously reported, an independent review committee assessment showed the obinutuzumab regimen reduced the risk for disease progression or death by 28% (HR = 0.72; 95% CI, 0.56-0.93). Researchers also reported a higher overall response rate (91% vs. 88%) and higher complete remission rate (28% vs. 27%) in the obinutuzumab group.
The most common side effects reported among obinutuzumab-treated patients were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation and diarrhea. The most common grade 3 to grade 5 adverse effects were low white blood cell count, low white blood cell count with fever, infusion reactions and low platelet count.
“[This] Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “We’re pleased we can now offer patients with this incurable blood cancer an initial treatment option shown to improve upon Rituxan, the standard of care in this setting for more than 10 years.”