Pharmacy

FDA concluded Avastin (bevacizumab) in combination with paclitaxel neither prolonged overall survival in metastatic breast cancer patients nor provided a sufficient benefit in slowing disease progression. The decision was followed by a review by the FDA advisory committee, which suggested removal of the breast cancer indication. Avastin in combination with paclitaxel got the green light in February 2008 under the agency's accelerated approval programme. Roche strongly disagreed with the decision and breast cancer patients have been testifying to an FDA panel. However, the FDA is unlikely to change its stand, seeing as how especially as five of the six members of the panel also voted against Avastin's use in breast cancer in July.

An eagerly anticipated two-day hearing into Roche's appeal against the USFDA proposal to pull Avastin's approval for breast cancer has brought more activity at the agency's headquarters in Maryland. After a review of four clinical studies,