National Brain Tumor Society Statement on the Full Approval of Avastin
Last night, we learned that the U.S. Food & Drug Administration (FDA) has granted full approval for the use of the drug Avastin (bevacizumab) to treat adult recurrent glioblastoma patients. In 2009, Avastin was granted conditional approval in this setting under the FDA’s accelerated or conditional approval program.
The FDA’s decision to move the drug from a conditional approval to a full approval means brain tumor patients and their doctors will be able to continue to have the option to utilize this drug in appropriate treatment regimens as determined by individual medical cases.
According to the drug’s manufacturer, Genentech – a member of the Roche Group, the decision to grant full approval to Avastin in recurrent glioblastoma was based on a totality of clinical data, including a recent phase III trial conducted by the European Organization for Research and Treatment of Cancer (EORTC) that evaluated the addition of Avastin to lomustine chemotherapy in 432 patients with previously treated glioblastoma. That trial found that although the addition of Avastin to chemotherapy did not significantly increase the average length of patients’ survival, it did delay disease progression and increase the percentage of patients that were able to discontinue steroid use, which is also important to patients.
It is important to note that though Avastin, on average, did not improve patient survival, we know from individual examples – as well as discussions with brain tumor patients and neuro-oncologists – that some patients do derive clinical benefits from the drug in the real world (non-clinical trial) setting. As such, it is significant that the FDA has confirmed that this drug will remain a ‘therapeutic tool’ in the toolkit for recurrent glioblastoma patients and is available for their doctors to consider in their treatment planning. It removes the concern that already limited therapeutic options for these patients would get smaller.
NBTS appreciates the FDA providing a conclusive decision and maintaining Avastin as an option for this community. We are equally appreciative of Genentech’s commitment to persist with the development of this treatment in a challenging, but critical, disease area like glioblastoma. NBTS continues to encourage more industry companies to consider glioblastoma drug development to help meet this major medical need.