FDA panel votes to yank Avastin indication

How does it feel to watch a billion dollars in revenue circle the drain? Just ask Roche executives; their blockbuster Avastin got the thumbs-down as a breast cancer treatment at yesterday's FDA advisory panel meeting. And if the agency follows that expert advice, the drug could lose up to $1 billion in annual sales, analysts say.

Committee members voted 12-1 to take back the drug's approval as a breast cancer treatment after sifting new study data that suggests Avastin isn't as effective against the disease as it appeared to be in earlier trials. The panel decided that chemotherapy plus Avastin didn't work any better than chemo alone. "I'm really not seeing that this has a benefit for patients," Natalie Compagni Portis, the patient representative on the committee, said during the meeting, as quoted by the New York Times. "Hope is very important, but to offer hope that isn't substantiated I don't think is responsible."

Even if the FDA does decide to yank the breast cancer indication, Avastin will still be approved for colon, lung, kidney and brain cancers. And doctors would still be able to use it off-label in breast cancer. But doctors might not want to. And, as the NYT points out, insurers might not pay. Hence the projected $1 billion sales drop, Sanford C. Bernstein analyst Tim Anderson tells Bloomberg. Eliminating U.S. breast cancer sales could cut Roche's earnings by about 5 percent, he said.

"We are disappointed by the committee's recommendation and believe Avastin should continue to be an option," says Sandra Horning, head of clinical development hematology/oncology at Roche, in a statement, promising to keep pushing FDA toward keeping the indication. The FDA is set to decide by Sept. 17.

- read the Genentech release
- read the NYT piece
- get more from Bloomberg
- see the MarketWatch news
- check out the coverage from Forbes

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