Roche announced that the European Commission has approved Gazyvaro (obinutuzumab), combined with bendamustine chemotherapy, to treat follicular lymphoma patients who have failed to respond to, or whose disease progressed despite, treatment with rituximab (MabThera) or a rituximab-containing regimen.
EU approval was based on data generated from GADOLIN, an open-label, randomized, Phase 3 clinical trial evaluating the combination of Gazyvaro and bendamustine, followed by Gazyvaro monotherapy, until disease progression or up to two years, compared to bendamustine monotherapy.
Results revealed that this treatment regimen led to a 52 percent reduction in the risk of disease progression or death compared to treatment with bendamustine alone, as assessed by an independent review committee. Median progression-free survival (PFS) in patients given the Gazyvaro regimen was more than double that of the bendamustine monotherapy arm (29.2 months versus 13.7 months, respectively).
Patients treated with the Gazyvaro regimen also showed a 38 percent reduction in the risk of death compared to those treated with bendamustine monotherapy.
“Today’s approval is a significant milestone in the treatment of people with follicular lymphoma in Europe,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release. “For those who fail to achieve durable disease control with MabThera-based treatment, Gazyvaro plus bendamustine is an important new treatment option that has been shown to reduce the risk of disease progression or death by more than half.”
The U.S. Food and Drug Administration (FDA) gave a similar approval to obinutuzumab as a follicular lymphoma treatment in relapsed patients in February based on this study’s findings. In the U.S., the drug is marketed as Gazyva.
Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL. During initial therapy, response rates to the current standard treatment (rituximab) are superior to 90 percent. But the disease has no cure and relapse is common, with the disease becoming more difficult to treat with each relapse.
Gazyvaro is also approved in Europe, in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukaemia (CLL) and comorbidities that make them unsuitable for full-dose fludarabine-based therapy.