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CDER prevails in Avastin hearing

June 29, 2011 11:53 PM UTC

Six members of FDA's Oncologic Drugs Advisory Committee (ODAC) unanimously backed CDER's proposal to withdraw accelerated approval for Genentech Inc.'s Avastin bevacizumab in combination with chemotherapy to treat first-line HER2-negative metastatic breast cancer. FDA Commissioner Margaret Hamburg will make a final decision on the proposal at a later date.

On the second day of a two-day hearing on the issue, the panel agreed with CDER that the two Phase III confirmatory trials to support full approval -- AVADO and RIBBON 1 -- failed to verify the clinical benefit of Avastin in combination with chemotherapy for metastatic breast cancer. The panel felt that the magnitude of benefit seen on the primary endpoint of progression-free survival (PFS), while statistically significant, was not clinically meaningful. They also did not feel the data confirmed the PFS benefit seen in the E2100 trial, which formed the basis of FDA's decision to grant accelerated approval in 2008. ...