Avastin® (bevacizumab) remains on the market in the US and is FDA-approved for advanced colon and rectal cancer in combination with chemotherapy, both as first-line and second-line therapy.
The public hearing held on June 28 and 29 reviewed the process began in December, 2010 to withdraw the FDA provisional approval of Avastin for metastatic, HER-2 negative breast cancer. It did not consider or change other label indications for colorectal, kidney, or small cell lung cancers or glioblastoma.
A final decision on breast cancer will be made by the FDA Commissioner Margaret Hamburg, MD. Until then the indication for breast cancer will remain on the FDA-approved label. Read the rest of this entry »