Roche receives EU approval of Gazyvaro in follicular lymphoma

Roche has announced that its cancer therapy Gazyvaro has been approved in Europe as a treatment for advanced follicular lymphoma.

The European Commission has approved Gazyvaro in combination with chemotherapy – followed by Gazyvaro maintenance among responders – as a new treatment for previously untreated cases of advanced follicular lymphoma.

This approval was based on positive data from the GALLIUM study, the first phase III study to show superior progression-free survival for a new therapy compared to Roche's own MabThera, the current standard of care.

Gazyvaro-based treatment was shown to reduce the risk of disease progression or death by 34 percent compared to MabThera-based treatment.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "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."

The drug is also approved in Europe for the treatment of chronic lymphocytic leukaemia and for follicular lymphoma patients who have failed to respond to prior MabThera treatment.

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