Summary
Avastin's recent FDA approval for m-breast cancer ( m-BCA) was lukewarm at best with no overall survival benefit yet and modest PFS data. European regulatory agencies usually require cost efficacy data and more strict data, which are not readily available for Roche/Genetech. The British market is not big for innovative agents like Avastin, so the company's decision is unlikely to impact a large company like Roche.
Analysis
Avastin ( Genentech/Roche) was recently granted restricted approval by FDA, based on modest efficacy data when added to Docotaxel in patients with front-line metastatic breast cancer.
The decision reversed an ODAC panel recommendation, in a rare move by the FDA, mostly due to political pressure from advocacy groups in an election year.
Such data is unlikely to pass the rigorous, cost-conscious regulatory processes of European agencies.
On ther flip side, such an expensive drug is unlikely to have a big market in a socialized medicine system as in the UK, so the loss to Roche is insignificant.
