Time to get back up on my soap box.
Next month, the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month.
The drug is Avastin (bevacizumab), a targeted monoclonal antibody that prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing.
Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other cancers.
The problem comes with breast cancer. Avastin was approved for breast cancer under an FDA program called “accelerated approval” in which the agency provides “conditional” approval for a life-saving drug that appears effective so as to get it to patients quickly while requiring that the manufacturer conduct more studies demonstrating its long-term effectiveness. About 90 drugs have been approved under the accelerated approval program in the past 20 years and none has ever had its approval revoked (one … Continue Reading