US FDA allows Genentech/Roche to present case for Avastin in metastatic breast cancer

In what is seen as a first-of-a-kind decision, the US Food and Drug Administration has granted a hearing to allow Genentech, a US subsidiary of Swiss drug major Roche (SIX: ROG), the opportunity to present its views on why Avastin (bevacizumab) should remain FDA-approved for metastatic breast cancer (mBC).

Late last year, the FDA recommended removing the breast cancer indication from the label for Roche best-selling cancer drug Avastin – which last year generated revenues of 6.46 billion Swiss francs ($6.79 billion), up 9% on 2009 - because it has not been shown to be safe and effective for that indication. At the same time, the European Medicines Agency decided that the product should remain an option in combination with paclitaxel (The Pharma Letter December 17, 2010). These decisions did not affect the drug’s use in other approved indications, such as in colon, lung, kidney and brain cancer. Also, just this week, the UK’s drug watchdog NICE again turned down National Health Service use of Avastin in metastatic breast cancer (TPL February 24).

Hearing set for late June