In late December, officials at the Food and Drug Administration announced plans to revoke approval of Avastin for the treatment of late-stage breast cancer. This move shocked much of the medical community — as it represents a huge step backwards in this fight against cancer.
Avastin works by cutting off the blood supply that cancerous tumors need to grow. Clinical studies proved that for women with stage IV breast cancer, Avastin bought them more time — weeks or months in which the cancer wasn’t able to gain ground or spread.
That’s why it had earned a key endorsement from the National Comprehensive Cancer Network. This not-for-profit alliance of nearly two dozen of the world’s top cancer centers have reviewed the studies on Avastin and affirmed its guidelines for using Avastin along with the chemotherapy agent Taxol to treat metastatic breast cancer.
So why is the FDA repealing the drug’s approval for this use? Agency officials argue that the drug doesn’t grant “enough” extra time for the average metastatic breast cancer patient to be worth it.
In response to the prospect of a withdrawal, scores of patients and their families launched heart-wrenching personal campaigns, begging the FDA to recognize that the extra weeks, months and in some cases even years Avastin may provide is absolutely “worth it” to them.
These patients know that every day in which their cancer doesn’t progress means more opportunities to do the things that make their lives uniquely worthwhile.
While research thus far hasn’t proven that, on average, Avastin prolongs life, it has provided clear evidence that the drug can slow the spread of cancer while improving quality of life. One study of patients taking Avastin with chemotherapy found that such treatment delayed tumor growth a median of about 11 months, nearly five months longer than chemo alone.
Avastin was being prescribed to 17,500 breast cancer patients each year.
Now that the FDA is pulling approval of Avastin for breast cancer patients, government and private health insurance companies will likely stop covering it, and few patients could afford to pay for it themselves, as treatment costs about $8,000 a month.
Nearly 1 in 8 American women will develop invasive breast cancer in their lifetimes, and the disease claimed 40,000 lives last year. Metastatic breast cancer patients respond to Avastin in dramatically different ways and some of those patients and their doctors insist it is their best hope for better days.
–Peter Pitts
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
