Avastin faces the FDA again on breast cancer

This week Avastin faces the FDA again. The agency ruled last year that Avastin does not increase overall survival or progession-free survival for women with breast cancer. But Roche/Genentech has come back to the FDA to challenge that decision. Analysts are not optimistic that the brand will survive with any breast cancer label but it is rare for the FDA to grant an appeal. So I would expect that many are interested in the results.

According to advocacy groups, there are 17,000 women on Avastin for advanced breast cancer. Our studies have shown that there are those who are convinced that Avastin has increased PFS. When the FDA repealed its support, many patients were extremely angry and the accused the agency of creating death panels. Their stories were difficult to read. And there are oncologists who believe that Avastin did/does work for certain patients.

Avastin is expensive at about $8,000/month so if the current ruling stands, it is likely most patients will not be able to continue on the drug as insurance coverage will be gone.

Genentech is willing to conduct more targeted studies to determine who is the best candidate for the drug and the FDA is open to more research. More data may pinpoint why some patients respond and others do not. While OS is the gold standard, PFS matters to patients and their families.

So on Tuesday and Wednesday of this week, 17,000 patients, their families and their medical teams will be holding their breadth.