FDA questions Avastin in breast cancer

FDA questioned the risk-benefit profile of Avastin bevacizumab from Roche (SIX:ROG; OTCQX:RHHBY) for first-line treatment of HER2-negative metastatic breast cancer in briefing documents posted ahead of Tuesday's Oncologic Drugs Advisory Committee meeting. Roche is seeking to convert Avastin's accelerated approval in the indication to regular approval, and to expand the label to include combination with docetaxel, anthracycline or capecitabine. The accelerated approval, granted in 2008, already includes combination with paclitaxel.

In the documents, FDA asserted that the Phase III AVADO and RIBBON-1 trials required to verify the drug's effect on progression-free survival (PFS) "failed to confirm the magnitude" of PFS improvement observed in the E2100 trial, which formed the basis for the initial approval. Additionally, the agency noted overall survival data showed hazard ratios favoring placebo in both AVADO and RIBBON-1, with the Avastin arms showing an overall increase in serious adverse events, Grade 3-5 adverse events and adverse events related to Avastin. Both trials did meet the primary endpoint of PFS compared to the placebo arms. ...