FDA Approves Gazyva to Treat Follicular Lymphoma

James Radke, PhD

The FDA has approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.
Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin’s lymphoma (NHL) and accounts for approximately 1 in 5 cases of NHL. It is considered incurable and relapse is common. In the United States, approximately 14,000 new cases of follicular lymphoma were likely diagnosed last year.
In 2015, the FDA designated Gazyva as an orphan drug for the treatment of follicular lymphoma.
Gazyva is also approved to treat chronic lymphocytic leukemia (in combination with chlorambucil).
The approval is based on results from the Phase III GADOLIN study, which showed that, in people with follicular lymphoma whose disease progressed during or within six months of prior Rituxan-based therapy, Gazyva plus bendamustine followed by Gazyva alone demonstrated a 52% reduction (HR=0.48, 95% CI 0.34-0.68, P < .0001) in the risk of disease worsening or death (progression-free survival, PFS), compared to bendamustine alone, as assessed by an independent review committee (IRC).
The safety of Gazyva was evaluated based on 392 people in the GADOLIN study with indolent NHL of whom 81% had follicular lymphoma. The most common Grade 3-4 side effects of this Gazyva regimen were low white blood cell counts, infusion reactions and low platelet counts. The most common side effects of this Gazyva regimen were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness and urinary tract infection.
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