Roche secures EU approval for Gazyvaro in new lymphoma indication
pharmafile | June 16, 2016 | News story | Research and Development, Sales and Marketing | EU, Gazyvaro, Roche, follicular lymphoma
Roche (SIX: RO) has announced that the European Commission has approved Gazyvaro (obinutuzumab), in combination with bendamustine chemotherapy, in patients with follicular lymphoma.
It is specifically indicated for people who did not respond or who progressed during or up to six months after treatment with Mabthera (rituximab) or a MabThera-containing regimen.
Follicular lymphoma is the most common type of indolent non-Hodgkin lymphoma. While initial therapy with MabThera can yield response rates as high as 90%, there is no cure for this disease and most patients will eventually relapse with each relapse making the disease more difficult to treat.
This is the second indication that Gazyvaro has been approved for in the EU, after it was approved in a specific indication for chronic lymphocytic leukaemia in 2014.
This new approval is based on results from pivotal Phase III trials which showed that Gazyvaro plus bendamustine, followed by Gazyvaro alone resulted in a 52% reduction in the risk of disease worsening or death, compared to bendamustine alone. Furthermore, median progression free survival was more than double that with bendamustine alone.
Sandra Horning, chief medical officer at Roche, says: “Today’s approval is a significant milestone in the treatment of people with follicular lymphoma in Europe. 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.”
Sean Murray
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