Roche has won European approval for cancer drug Gazyvaro as a treatment for some patients with previously treated follicular lymphoma, the most common type of indolent non-Hodgkin's lymphoma.
The European Commission has cleared the drug's use alongside bendamustine chemotherapy followed by Gazyvaro (obinutuzumab) alone as a new treatment for patients who have not responded to a MabThera (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.
Gazyvaro is a 'type II' anti-CD20 monoclonal antibody designed to attack blood cancers more aggressively than 'type I' treatments such as MabThera, shown in clinical trials to significantly reduce the risk of disease progression or death.
Approval was based on Phase III results from the GADOLIN study, which showed that, in people with follicular lymphoma whose disease progressed during or within six months of prior Rituxan-based therapy, the Gazyvaro-based treatment regimen demonstrated a 52 percent reduction in the risk of disease worsening or death, compared to bendamustine alone.
Median progression-free survival was more than double that with bendamustine alone (29.2 months vs. 13.7 months), and those taking Gazyvaro also showed a 38 percent reduction in the risk of death, the firm noted.
On the safety side, the most common Grade 3-4 side effects of the Gazyvaro regimen were low white blood cell counts, infusion reactions and low platelet counts, while most common side effects were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhoea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness and urinary tract infection.
Every day, more than 50 people in Europe are diagnosed with follicular lymphoma. The disease becomes more difficult to treat at each relapse, and if a patient does not respond or relapses during or within six months of MabThera-containing treatment, they will likely need a different treatment, but there are little options at this stage.
Gazyvaro is also approved in Europe to 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. The drug is also available for both CLL and follicular lymphoma indications in the US, where it is sold by Genentech as Gazyva.