Source:
APAP
FDA Clears Avastin for Breast Cancer
Friday February 22, 5:07 pm ET
By Matthew Perrone, AP Business Writer
FDA Approval for Genentech's Avastin May Open Door to Broader Cancer Drug Standards
WASHINGTON (AP) -- A drug made by Genentech received federal approval on Friday to treat breast cancer, a decision that could represent a major shift in standards for assessing the effectiveness of cancer medicines.
Going against the recommendation of its advisory panel, the Food and Drug Administration cleared Genentech's Avastin, which is already approved for treating lung and colon cancer, based on findings that it slowed tumor growth.
The agency has traditionally approved drugs for late-stage cancer if they extended, or improved the quality of, patients' lives. Avastin showed neither, according to Genentech's application.
Wall Street analysts believe FDA's Avastin decision opens the door for other cancer drugs to be approved for their tumor-shrinking capabilities -- a trend that worries some health experts.
Read more:
http://biz.yahoo.com/ap/080222/cancer_treatment_fda.html
In clinical trials, Avastin demonstrated the longest reported "progression-free survival" for patients with advanced breast cancer. That means they live longer before their disease spreads or worsens. An initial study submitted to the FDA showed that Avastin in combination with Taxol (another cancer therapy) delayed the growth of tumors by about 11 months -- some five and half months longer than Taxol alone. Additionally, more than twice as many patients experienced significant tumor shrinkage.