Patients, scientists square off on Avastin at FDA

Yesterday's hearing about Avastin's use in breast cancer encapsulated some of life's big conflicts: individual versus society, emotion versus reason, faith versus science. Patients pleaded with the FDA to keep Avastin's indication for breast cancer, the New York Times reports, contending that some individuals have benefited greatly from the drug, even if five clinical trials haven't found a survival benefit in patients overall. Some cried. Many were angry.

But not only did FDA scientists return again to study data showing the Roche drug didn't prolong life and only delayed cancer growth by up to three months. They also disputed the idea that some women are "super responders." No matter how much the data was sliced and diced, the agency couldn't tease out proof that Avastin helped a subgroup of women live substantially longer than women in the control group. "We're just not seeing that population," one FDA official said (as quoted by the NYT).

Patient groups are split on the FDA's recent move to revoke Avastin's indication for breast cancer. Some testified on behalf of the drug, while others--including the National Breast Cancer Coalition--stood with the FDA. The former said that the indication should stand, partly because revoking it could discourage R&D. The latter cited Avastin's sometimes-serious side effects and maintained that scientific data should determine Avastin's fate, not "any one individual story, no matter how compelling."

Today, Roche's Genentech unit, which developed Avastin, has its opportunity to present a case in favor of Avastin's breast cancer use. The company has criticized the FDA's interpretation of the study data, and in a statement after yesterday's hearing, said it welcomed the opportunity to show why the drug should stay approved for breast cancer. There's plenty at stake. Losing the indication could cut as much as a billion dollars off Avastin's annual sales. The drug would of course remain on the market, approved for use in several other cancers.

- check out the Genentech release
- read the NYT coverage
- get more from Reuters
- see the Wall Street Journal story