Recently the FDA revoked approval of a best-selling drug, Avastin, for treatment of breast cancer. Ever since, arguments for and against the removal have been voiced in blogs and major media by a wide variety of people with different points of view. Let's look at some of the issues in the context of Healthy Survivorship.
Avastin (bevacizumab) is the first FDA-approved drug that works by inhibiting the development of new blood vessels needed to carry nutrients to a tumor.
In 2004, the FDA granted approval for first-line treatment of patients with metastatic colorectal cancer based on standard, rigorous studies. Over the next five years, FDA granted approval for treatment of a few other cancers.
The situation with breast cancer has been special. FDA approval in 2008 was conditional, because it was based on one study that had serious weaknesses. The study was not blinded. And the study measured "progression-free survival" (i.e., how long the drug kept advanced tumors from growing larger) and not survival or quality of life.
The FDA made it clear that it was willing to grant "accelerated approval" only if the producer -- Genentech -- conducted additional, rigorous, double-blinded studies to validate the risk-benefit ratio for patients.
In July 2010, the FDA advisory committee concluded from the new studies that the drug failed to extend life, slowed tumor growth for far less time than in the original study, and increased patients' risk for life-threatening complications.
A year's worth of wrangling led to the 69-page FDA decision to revoke approval.
What does all this mean?
This is a hard one. It's what makes having a decision-making job at the FDA so hard. Pulling Avastin from that market must not have been an easy resolution to the problem, as evidenced merely by the length of the decision to revoke.
Posted by: Jan Hasak | November 30, 2011 at 10:40 AM
Dear Jan,
Exactly. In my next post, I'll address the FDA's challenge.
With hope, Wendy
Posted by: Wendy S. Harpham, MD | November 30, 2011 at 11:27 AM
Wendy,
You are such an incredible writer. Thanks for your passion, insight, knowledge, skill, concern. You are spot on, every time, what a gift. The cancer community needs the beacon named Wendy Harpham to guide us through the news and information fog. We are grateful.
Your friends in Minneapolis,
-Ben and Janice Haines
Posted by: Ben Haines | December 01, 2011 at 05:47 AM
Thank you for your kind words. This is my way of expressing my gratitude for my survival. With hope, Wendy
Posted by: Wendy S. Harpham, MD | December 01, 2011 at 06:09 AM