FDA may revoke breast cancer drug

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TEXT OF INTERVIEW

Stacey Vanek-Smith: The Food and Drug Administration is expected to revoke its approval of the nation's best-selling cancer drug this week. Avastin is mainly used by patients with very advanced breast cancer. From the health desk at WHYY in Philadelphia, our own Gregory Warner joins us live. Good morning, Gregory.

GREGORY WARNER: Good morning.

VANEK-SMITH: Gregory, an FDA advisory committee says the FDA should take Avastin off the shelves. Why is that? Are they saying it doesn't really help breast cancer patients?

WARNER: They're saying it doesn't help most breast cancer patients. There are some patients -- maybe their genetics of their cancer is different -- who might get some benefit from this drug, but many won't. And the tendency with late-stage cancer treatments is to throw everything every treatment at them even if it doesn't work or if the side effects are crippling.

I talked about this to Bob Goldberg at the Center for Medicine in the Public Interest. He says that if the FDA revokes, they're basically sending a message: not "this never works," but more like "this probably doesn't work for you so you and your doctor should think very hard about whether it does." And revocation is the means they have.

BOB GOLDBERG: And right now, this idea of idea of revocation is a very crude tool. You know it can dash hopes unrealistically or it can raise expectations unrealistically.

VANEK-SMITH: Gregory, what are the economics of this decision?

WARNER: Well, Avastin is on track to becoming the top selling drug in the world. In part because it is so expensive -- about $50,000 per patient. It still is approved for lots of other cancers -- colon cancer, lung cancer, brain cancer. So if the FDA revokes it for cancer, women can still get it if their doctor prescribes it off label. It will just be a lot harder to get an insurance company to pay for it and Roche could lose half-a-billion in sales.

VANEK-SMITH: So is this a message to the drug industry as a whole?

WARNER: The bar is being raised. I mean not all drugs work on all people. And it's going to be increasingly up to drug companies not just to say "hey, this drug works" but who does it work for.

VANEK-SMITH: Our own Gregory Warner in Philadelphia. Thank you, Gregory.

WARNER: Thanks a lot.

About the author

Gregory Warner is a senior reporter covering the economics and business of healthcare for the entire Marketplace portfolio.

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