FDA Takes Cautious Approach to Avastin as Metastatic Breast Cancer Treatment
When the news broke December 5 that an FDA expert panel had voted 5-4 to reject Avastin (bevacizumab) as an approved breast cancer treatment because of serious side effects, I experienced a moment of deep sadness, as well as some frustration. Avastin, a cutting-edge, “targeted drug” therapy for women with metastatic breast cancer, has been shown (when taken with chemotherapy) to give these women an extra 5 1/2 months of time when their cancer doesn’t grow and spread. And when you have advanced breast cancer, with the clock ticking loud and clear for you, I can only imagine how precious those 5 1/2 months might be.
This isn’t a cut-and-dry case of an ultra-cautious government agency, nor is it an example of bungling bureaucracy. No, Avastin has a serious downside, affecting up to 20% of those who take it. Side effects include high blood pressure, blood clots, heart attacks – and death. Six of the 363 women in Avastin’s chief clinical study – 1.7% – died, compared with none of the 348 patients who had chemo without Avastin. That’s huge. And it would certainly rule out Avastin as therapy for the majority of women with breast cancer.
But… for those women facing the end of life, with just the slightest whisper of hope that they’ll survive, perhaps that 5 1/2 months means they’ll see a son graduate from high school, a daughter get married, or a grandchild born. They may be willing to take the 1.7% chance; which, looked at another way, is a 98.3% chance of living.
Avastin gained FDA approval for the treatment of colon cancer in 2004, and for lung cancer in 2006. In those two cancers, its benefit was judged to outweigh its negative side effects (which include blood clots and congestive heart failure). Avastin is also being tested in patients with pancreatic and ovarian cancer; it’s expected that the total development program for the drug will include over 40,000 patients worldwide.
As the first drug that stops cancer by cutting off the blood supply to tumors, it marks a huge step in a new and promising direction for researchers. And it raises hopes for men and women facing some of the most aggressive, lethal forms of cancer. But, unless the FDA ignores its panel’s recommendation to reject it (unlikely; the decision will be made Feb. 23), Avastin won’t officially be available to breast cancer patients. In America, at least; Avastin has already been approved for breast cancer patients in Europe.
But, we’re just talking official approval here. American breast cancer patients are already taking Avastin on an “off label” basis, which means their oncologists are prescribing it because they believe its benefits outweigh its costs. In fact, Avastin manufacturer Genentech’s off-label sales of Avastin for breast cancer in this country amount to between $200 million and $250 million annually. So, what more would official FDA approval gain us? The greater likelihood that insurance will pay for the treatment. Right now, insurers are acting on a case-by-case basis, often rejecting patients’ claims. And the cost of rejection is high: Avastin treatments run a breast cancer patient upwards of $100,000 a year. Even with insurance coverage, co-pays can run $10,000/$20,000 a year. That’s beyond the means of most of us.
So it all boils down to this. First, do the benefits of Avastin outweigh its risky side effects, in the opinion of those most critically concerned – women dying of metastatic breast cancer? And second, even if a woman decides to risk the side effects, how can she afford the cost? Tough questions; and for the time being, no answers.
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