Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Breast Cancer Health Center

Font Size

FDA Moves to Pull Avastin Breast Cancer Approval

Roche/Genentech Will Fight Avastin/Breast Cancer Decision at FDA Hearing

Avastin Breast-Cancer Approval: FDA, European Medicines Agency Differ continued...

The three new trials used different chemotherapies than the first trial. Because of this, the European drug agency yesterday reaffirmed its approval of Avastin plus paclitaxel, but not for other chemotherapy combinations. The FDA feels differently, said Janet Woodcock, MD, director of the FDA's center for drug evaluation and research.

"The EMA accepts the magnitude of [delayed tumor progression seen in the first study] as a clinical benefit," Woodcock said at the news conference. "Now we have other trials with a much smaller increase in [delayed tumor progression], no additional benefit, increased side effects, and no increase in survival. So these subsequent trials did not show a clinical benefit."

The studies did show that Avastin carries a number of risks. In addition to the common side effects of nosebleed and high blood pressure, serious side effects include massive bleeding; perforation of the nose, stomach, and intestines; severe high blood pressure; blood clots, heart attack; kidney damage, wounds that do not heal; and a condition called RPLS characterized by headache, confusion, seizures, and vision loss.

Despite these risks, many women facing metastatic breast cancer have petitioned the FDA to retain their access to Avastin. Without FDA approval, Avastin might not be reimbursed by insurance companies -- or by Medicare/Medicaid, which had postponed its decision on whether to cover this use of the drug pending the FDA action. The wholesale price of Avastin is $7,500 a month, which does not include infusion costs.

The FDA is not allowed to consider cost in its approval decisions.

The FDA says it will work with Genentech to design clinical trials to explore whether there is a subset of women with metastatic breast cancer who benefit from Avastin. But Patricia Keegan, MD, director of the FDA's division of biologic oncology products, said at the news conference that the four clinical trials submitted to the FDA offer no hint about which women might benefit.

1 | 2

Today on WebMD

Breast Cancer Overview
From self-exams and biopsies to reconstruction, we’ve got you covered.
Dealing with breast cancer
Get answers to your questions.
woman having mammogram
Experts don’t agree on all fronts, but you can be your own advocate.
woman undergoing breast cancer test
Many women worry. But the truth? Most abnormalities aren’t breast cancer.
Breast Cancer Treatments Improving
Resolved To Quit Smoking
Woman getting mammogram
Screening Tests for Women
ovarian cancer overview slideshow
serious woman
what is your cancer risk
10 Ways to Revitalize Slideshow