The US Food and Drug Administration (FDA) has granted approval for Roche’s approved Gazyva (obinutuzumab) plus bendamustine chemotherapy, followed by Gazyva alone as a new treatment for people with follicular lymphoma.
The drug has been approved to treat patients who did not respond to a Rituxan (rituximab) or had their follicular lymphoma return after such treatment.
Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL). It is considered incurable and relapse is common.
Gazyva / Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system.
The company noted that this is the second FDA approval for Gazyva based on a positive Phase III study.
The Phase III Gadolin study evaluated Gazyva plus bendamustine followed by Gazyva alone until disease progression or for up to two years compared to bendamustine alone.
Gadolin included 413 patients with indolent (slow-growing) NHL, including 321 patients with follicular lymphoma, whose disease progressed during or within six months of prior MabThera / Rituxan-based therapy.
Roche global product development head Dr Sandra Horning said: “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.
“Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”
Gazyvaro is currently approved in more than 60 countries in combination with chlorambucil, to attend to people with previously untreated chronic lymphocytic leukaemia.
1 March 2016