FDA revokes breast cancer drug Avastin

BRIAN WILLIAMS, anchor: There's a big decision to report tonight about a drug for breast cancer that some women contend saved their lives. Tonight though the government says the science tells a different story, and so the FDA is revoking the approval of the drug Avastin as a breast cancer treatment. Our chief science correspondent Robert Bazell has more on this highly charged decision .

ROBERT BAZELL reporting: Shannon Morgan , who has advanced breast cancer , is devastated by the FDA commissioner 's decision that Avastin no longer can be marketed as a treatment for her disease.

Ms. SHANNON MORGAN: It's heartbreaking. I cried. My first thought was, 'She's just gave me a death sentence.'

BAZELL: But at three FDA hearings on whether Avastin should be approved for breast cancer , experts repeatedly testified that despite emotional appeals...

Unidentified Woman #1: I owe the last seven and a half years to Avastin .

Unidentified Woman #2: Avastin gives us hope.

BAZELL: ...the evidence did not prove the drug was effective. Still, FDA commissioner Margaret Hamburg said her decision to follow the advisory panel's recommendation was a difficult one.

Dr. MARGARET A. HAMBURG: Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing.

BAZELL: Avastin remains on the market as a treatment for several other cancers, meaning doctors can prescribe it for so-called off label use for breast cancer . The big question is whether Medicare and private insurance companies will pay the steep cost, $88,000 a year. So far Medicare has said it will pay. Avastin was approved for breast cancer in 2008 under an accelerated approval program with one stipulation, that manufacturer Genentech provide better data that it works. Most cancer doctors agreed that so far the company has not offered that proof.

Dr. JENNIFER LITTON (MD Anderson Cancer Center): I don't think the decision is surprising given the data that the FDA had, but there may be a group of women who could definitely benefit from this drug and have benefited.

Ms. MORGAN: People who have cancer, they just want some hope.

BAZELL: In today's decision , the FDA says it would be open to further studies of women like Shannon Morgan to determine how much it helps them and if there is some genetic marker to determine which patients will benefit. This decision is getting a lot of attention because it pits such powerful emotions against the best science available. And it is all in the context, Brian , of these very expensive cancer drugs that we've talked about so often.

WILLIAMS: Interesting decision today. Robert Bazell here with us. As always, Bob , thanks.