Genentech announced that the the U.S. Food and Drug Administration (FDA) has approved the combination of Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva for the treatment of people with follicular lymphoma who were unresponsive to, or whose lymphoma returned after, a regimen containing Rituxan (rituximab).
Follicular lymphoma is the most frequent indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL), representing nearly one in every five cases. It is currently incurable, with common relapses. “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,” Sandra Horning, MD, Genentech’s CMO and head of Global Product Development, said in a press release. “Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”
The FDA approved the treatment based on results from the Phase 3 GADOLIN study, which showed that — in patients with follicular lymphoma whose condition progressed during or within six months of taking Rituxan — Gazyva plus bendamustine followed by Gazyva was effective, with a 52 percent reduction in the risk of disease worsening or mortality when compared to bendamustine alone. The analysis was made by an independent review committee (IRC).
Gazyva was evaluated in the GADOLIN study for its safety in 392 people with indolent NHL, of whom 81 percent had follicular lymphoma. The most severe therapy adverse effects reported were low white blood cell counts, infusion reactions, and low platelet counts. The most common reports were infusion reactions, low white blood cell counts, fatigue, cough, diarrhea, fever, decreased appetite, muscle pain, sinusitis, and general weakness.
Gazyva in combination with chlorambucil is already approved in the U.S. as a therapy for people with previously untreated chronic lymphocytic leukemia (CLL), with the FDA decision based on the pivotal CLL11 study. Genentech has also submitted Gazyva marketing applications to other regulatory authorities, including the European Medicines Agency (EMA).