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FDA approved obinutuzumab (Gazyva, Genentech) for the treatment of certain patients with follicular lymphoma. Here are the top 5 things to know about Gazyva.
Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL) and develops when the body makes abnormal B-lymphocytes. Common signs of follicular lymphoma include enlargement of the lymph nodes in the neck, underarm, stomach, or groin, as well as fatigue, shortness of breath, and weight loss.
"People with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back," said Sandra Horning, MD, chief medical officer and head of global product development for Genentech. "Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death."
Here are the top 5 things to know about Gazyva:
1. Gazyva is a humanized anti-CD20 monoclonal antibody that works by binging to CD20, a protein found only on B-lymphocytes. Gazyva attacks the targeted cells both directly and together with the body’s immune system.
2. Gazyva was originally approved in 2013 for use in combination with chlorambucil for previously untreated chronic lymphocytic leukemia. FDA has now approved Gazyva plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a rituximab-containing regimen, or whose follicular lymphoma returned after such treatment.
3. FDA’s approval is based on results from the phase 3I Gadolin study, which included 321 patients with follicular lymphoma whose disease progressed during or within six months of previous rituximab-based therapy. The trial evaluated the use of Gazyva plus bendamustine followed by Gazyva alone until disease progression or for up to two years, and compared it with bendamustine alone. Results showed a clinically significant improvement in progression-free survival with the Gazyva-containing regimen compared to bendamustine alone.
4. The most common side effects associated with the use of Gazyva in clinical trials included infusion reactions, low white blood cell counts, nausea, fatigue, cough, and constipation.
5. Gazyva is also being studied in a large clinical program for use in diffuse large B-cell lymphoma and in first line indolent NHL.