The US Food and Drug Administration has granted full approval for Avastin (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease).
Blockbuster cancer drug Avastin, from Genentech, the US biotech subsidiary of Swiss pharma giant Roche, was previously granted provisional approval in this setting under the FDA's accelerated approval program.
“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning, chief medical officer and head of global product development.
“Delaying disease progression and reducing the need for corticosteroids over the course of treatment are considered important goals for those impacted by this devastating disease where patients have limited treatment options,” Dr Horning added.
This conversion to full approval was based on the totality of evidence of Avastin in glioblastoma, including data from the Phase III EORTC 26101 study.
Avastin, which generated sales of around 5 billion Swiss francs ($5.1 billion) in the first nine months of this year, is now approved in the USA for nine distinct uses across six different types of cancer.
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