Roche group Genentech has secured US approval for cancer drug Gazyva as a treatment for some patients with previously treated follicular lymphoma, the most common type of indolent non-Hodgkin's lymphoma.
The US Food and Drug Administration has cleared the drug's use alongside bendamustine chemotherapy followed by Gazyva (obinutuzumab) alone as a new treatment for patients who have not responded to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.
Gazyva is a 'type II' anti-CD20 monoclonal antibody designed to attack blood cancers more aggressively than 'type I' treatments such as Rituxan, shown in clinical trials to significantly reduce the risk of disease progression or death.
Approval in this setting came after Phase III results from the GADOLIN study showed that, in people with follicular lymphoma whose disease progressed during or within six months of prior Rituxan-based therapy, Gazyva plus bendamustine followed by Gazyva alone demonstrated a 52 percent reduction in the risk of disease worsening or death, compared to bendamustine alone.
On the safety side, the most common Grade 3-4 side effects of the Gazyva 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.
The drug is already on the US market in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia (CLL).