FDA Approves New Option For Certain People With Previously Treated Follicular Lymphoma

February 26th, 2016

On February 26, 2016, the FDA approved Gazyva® (obinutuzumab) in combination with 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.

News in brief

  • This Gazyva regimen reduced the risk of disease worsening or death (progression-free survival, PFS) by about half compared to bendamustine alone in the Phase III GADOLIN study
  • Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin’s lymphoma (NHL) and accounts for approximately one in five cases of NHL
  • Gazyva is also approved in the United States in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL)

Supporting Information

Sandra Horning, M.D.

"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. Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death."