FDA Decision on Avastin

Introduced: August 01 2011

By IWD Member, Missy: Recently there was an editorial in The Wall Street Journal regarding a drug called Avastin. This is a cancer drug that I am very interested in seeing re-approved for women with metastatic breast cancer—three of the ugliest words in the English language. It was approved at one time and was effective for some of my fellow metastatic breast cancer patients I've gotten to know. This means our cancer has returned and is considered terminal but not untreatable.


The unique quality of Avastin is that it cuts off the blood supply to the cancer cells making it impossible for them to grow. All three of my oncologists lament that an effective weapon has been removed from their arsenal of cancer-fighting drugs. According to several articles in a recent issue of Cure Magazine, which is an excellent magazine with a focus on cancer, the FDA has refused to look at individuals w/in the clinical trial who had been helped by Avastin and instead focused purely on the broad statistics. The FDA committee which recommended this approach was made up of a group who had no relatives with cancer and none of them were oncologists.  One factor behind their negative recommendation was the "terrible" side effects of Avastin. The truth is there are "terrible" side effects to almost every cancer fighting drug. With the exception of Herceptin, I've  experienced some fairly difficult side effects with every cancer-fighting drug I've taken. But I am highly motivated to endure these side effects because they extend my life and it is still a quality of life that allows me to enjoy my family, friends, and everything that makes life so fabulously sweet.  No one is forced to take these drugs, but for those of us with late stage, recurring breast cancer Avastin was another good option.  Waging war with cancer requires many drugs.  A drug may be highly effective for 6 months and then cancer, relentless killer that it is, finds a way around it.


The other interesting component in all this is that Avastin, like most cancer- fighting drugs, is also incredibly expensive for insurance companies. There is some suspicion that insurance companies are dragging their feet and lobbying the FDA hard to stick by their refusal to re-approve Avastin for Metastatic Breast Cancer.  As the WSJ editorial states Genentech,  the drug company that makes Avastin, is so sure it's effective for patients with metastatic breast cancer they are mounting another extremely expensive clinical trial.  Unfortunately, those of us in the later stages of this war may not have the luxury of waiting for the trial to be completed... Individual deaths aren't a statistic the FDA seems willing to consider. This is an emotional issue for me but it's also part of the larger health care debate.


Note from IWD:  On November 18, 2011, FDA Commissioner Margaret A. Hamburg, M.D., announced she was revoking the agency’s approval of the breast cancer indication for Avastin.