Non-Profit Breastcancer.org Shares Concerns with FDA on Avastin Breast Cancer Recommendation
ARDMORE, Pa., Dec. 16, 2010 /PRNewswire-USNewswire/ -- Dr. Marisa Weiss, president and founder of Breastcancer.org and a breast oncologist in the Philadelphia area submitted a letter to the U.S. Food and Drug Administration prior to the Oncology Drug Advisory Committee (ODAC) meeting to review data for Avastin's use in metastatic HER2-negative breast cancer. In light of today's news that the FDA has recommended removing Avastin's approval to treat breast cancer, Breastcancer.org is making public Dr. Weiss' ODAC letter in its entirety.
Breastcancer.org's position remains unchanged by today's ruling.
Dear ODAC Committee Members:
As you consider label changes for Avastin, Breastcancer.org asks you to consider the treatment needs, expectations, and preferences of women diagnosed with metastatic breast cancer. In contrast to most women with early-stage breast cancer, most women with metastatic disease need continuous treatment in order to live. Despite the desperation many people with metastatic disease experience, they often have a remarkable ability to measure the pros and cons of each treatment decision with purpose, clarity, and precision. No two women or their cancers nor their treatment histories are the same. Aggregate clinical trial results include individuals with greater than expected benefit as well as those with a disappointing response. We doctors are limited in our ability to figure out who will and who won't get the important benefit of any particular treatment whether in the first-line setting or beyond. But we must have treatment options to turn to for our patients who need and desire them. Women with metastatic disease are prepared to make treatment decisions with greater risk since prior forms of treatments have already failed them. They deserve that choice.
As a non-profit organization dedicated to providing the most reliable, complete, and up-to-date information about breast health and br