FDA To Remove Avastin From Arsenal For Metastatic Breast Cancer

Patients who have lung, brain, kidney and colon cancers can still get Avastin treatments, but the Food and Drug Administration has decided that they will revoke their approval of the drug for use in metastatic breast cancer. Oncologists would still be able to prescribe Avastin to treat metastatic breast cancer, but because the FDA may change its status, health insurance won't cover the cost. Patients would be facing the possibility of paying $8,000 a month out of their own pockets for Avastin - a real strain for any budget - but particularly hard on those who have already spent quite a bit on previous drugs, surgeries, and therapies to try to extend their lives. For some of these breast cancer patients, Avastin has been the last chance. The drug's maker - Genentech - will appeal the FDA's decision to practically deny treatment to some metastatic breast cancer patients. While the appeal is pending, and if a hearing takes place, Avastin's status remains unchanged. That means that patients who are currently taking Avastin should stay tuned and take note of updates on this issue.

The Food and Drug Administration had rushed Avastin through it's approval process two years ago, as the drug looked like the best new targeted biological therapy when used with Taxol (paclitaxel). In Europe, the combination of Avastin and Taxol is used for first-line treatment of metastatic breast cancer. The European Medicines Agency (EMA) stated that, "the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer." But the U.S. FDA granted its initial approval on a condition which they say has not been met. The FDA required that Avastin be put through additional clinical trials to see if it would live up to initial results. Follow-up studies were done, but the FDA says that Avastin's somewhat limited benefits didn't outweigh its risks and side effects. According to the later studies, Avastin did not inhibit tumor growth enough to make it worthwhile for patients to endure the side effects, without reaping the benefit of greater life expectancy. In plain English, the FDA says that Avastin didn't slow down tumors and make patients live longer without also doing them harm from serious side effects - and we're talking about patients who have already survived a battery of previous chemotherapies, surgeries, and other treatments.

Not all cases of metastatic breast cancer are the same, so each patient may respond to a different treatment. While there are genetic tests that can help predict which cancers will respond to particular drugs, these tests do not yet cover all types of breast cancer. Some patients believe that Avastin is holding their breast cancer at bay, providing them more time with their families. Even some doctors, such as Eric P. Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute, say, "This is not a worthless drug by any means. There is almost certainly a group of women who get a big benefit. " Fran Visco, of the National Breast Cancer Coalition disagrees, saying, "The FDA should never have approved Avastin for breast cancer to begin with. We don't see evidence of benefit, but we do see evidence of harm." Visco is alluding to the possible side effects of Avastin, which can include internal bleeding, colon perforation, blood clots, and heart failure.

But some suggest that the fight over Avastin is about money. Genentech makes $5.8 billion each year on the drug, $855 million of which comes from use in breast cancer treatment. If Genentech can't sell its blockbuster drug to breast cancer patients, that's a hefty slice of income it has to forfeit. No wonder they are appealing the FDA decision! It's not just about altruistic motives, even though Avastin's maker does offer patient assistance - which they cap at $57,000 per year for low-income women. That's roughly 7 treatments per patient, per year. Metastatic breast cancer patients may need more, to be properly treated with Avastin.

Others argue that the real controversy is actually about who gets to decide which drugs you can be treated with? Does the U.S. FDA - a government agency that is charged with protecting patients and regulating costs - get to decide? Do the drug companies who spend on research, development and marketing of their products get to offer their medicines to anybody who may be able to afford them? Or does your oncologist become the final arbitor of what you can and can't be treated with - depending on whether or not your insurance - if you have any - will help cover the cost?

The Komen Foundation has made a statement on the matter, saying that they hope any patients who are actually benefiting from Avastin will continue to be covered by their insurance for its use. This comes back to the critical question - who will benefit from Avastin, and how do we predict who those patients are? "We are also urging Genentech/Roche to continue research on a biomarker for Avastin to determine which women will benefit from the drug. We are supportive of the drug development process and hope that manufacturers will continue to develop medications for the treatment of metastatic breast cancer. We will only succeed in finding new treatments for cancer by bringing new drugs to the clinic," said Elizabeth Thompson, president of Komen for the Cure.