The European Commission has approved Roche’s Gazyvaro (obinutuzumab) for previously untreated patients with advanced follicular lymphoma. The treatment is approved in combination with chemotherapy and should be followed by Gazyvaro maintenance therapy.
The approval of Gazyvaro, which is marketed as Gazyva outside Europe, is based on data from a Phase 3 trial showing that the drug increased progression-free survival by 34% compared to a MabThera (rituximab)-based treatment.
Treatments containing MabThera — also developed by Roche — are currently the standard of care for advanced follicular lymphoma.
“Every year an estimated 19,000 people in Europe are diagnosed with follicular lymphoma, which is considered to be incurable. We are pleased that with today’s approval of Gazyvaro, these patients now have an improved initial treatment option available to them,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a press release.
“By challenging our own MabThera medicine head-to-head, we have been able to set a new standard of care for people with follicular lymphoma,” she added.
The Phase 3 GALLIUM trial (NCT01332968) enrolled 1,401 patients with previously untreated indolent non-Hodgkin lymphoma (iNHL), of which 1,202 had follicular lymphoma.
Data were first reported in December 2016 at the 58th American Society of Hematology Annual Meeting (ASH 2016).
An independent review committee determined that the reduced risk of disease progression or death was somewhat lower than the investigators’ assessment, at 29%, but that still is a significant improvement.
While median progression-free survival had not been reached in any of the groups, analyses showed that 80% of Gazyvaro-treated patients had not progressed at three years, compared to 73% in the MabThera group.
The trial did not report any new safety issues not seen in earlier trials of the two drugs combined with chemotherapy.
The U.S. Food and Drug Administration is currently reviewing Gazyva as a first-line follicular lymphoma treatment.
Gazyvaro was approved earlier in Europe and the U.S. in combination with bendamustine for patients with follicular lymphoma who relapsed or did not respond to an earlier treatment. Its first approval in both regions, however, was for patients with chronic lymphocytic leukemia who were unsuitable for full-dose fludarabine-based therapy.