ARTICLE | Clinical News

Avastin bevacizumab regulatory update

July 26, 2010 7:00 AM UTC

FDA's Oncologic Drugs Advisory Committee voted 12-1 to recommend removing the first-line treatment of HER2-negative metastatic breast cancer indication from the label of Avastin bevacizumab. The company is seeking to convert Avastin's accelerated approval, which is for use in combination with paclitaxel and was granted in 2008, to full approval in the indication.

Noting similar concerns as had been expressed in FDA's briefing documents, ODAC voted 13-0 that the totality of data from Roche's Phase III AVADO and RIBBON 1 trials had failed to confirm the magnitude of progression-free survival (PFS) observed in the E2100 trial, which had formed the basis for the initial accelerated approval. While the 2 confirmatory studies met the primary endpoint of PFS vs. placebo, the panel believed Avastin's risk-benefit profile does not support continued licensure for the indication, particularly in light of a lack of overall survival advantage and an increased incidence of drug-related adverse events. ...