US FDA advisory panel nixes Roche's Avastin for breast cancer; but good news on Lucentis in DME

Genentech, the US subsidiary of Swiss drug major Roche (RGO: SIX), suffered a blow yesterday, when, after a two-day appeal hearing, a US Food and Drug Administration advisory panel unanimously (six to zero) voted that the company’s Avastin (bevacizumab) should not stay on the market for the treatment of breast cancer, saying that it was neither effective or safe for the treatment of the condition.

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.

Subsequently, in what is seen as a first-of-a-kind decision, the FDA granted a hearing to allow Genentech the opportunity to present its views on why Roche’s near $6.8 billion-a-year Avastin should remain FDA-approved for metastatic breast cancer (TPL February 25).