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By Thomas Saphner, MD, FACP — Green Bay Oncology
Principal Investigator, St. Vincent Regional Cancer Center

You may have heard about the Avastin congressional hearings earlier this summer. The hearings were prompted by Avastin’s maker, Genentech, who appealed an earlier Food & Drug Administration (FDA) decision to rescind approval for the drug bevacizumab (brand name Avastin) as treatment for metastatic breast cancer.

The testimony of healthcare professionals and drug researchers, patients and family members was extensive and, at times, emotional. In the end, the FDA chose to rescind approval for bevacizumab treatment of breast cancer, though it is still approved for treatment of cancers of the colon, lung, kidney and brain.

How could this happen?

Simply put, the drug turned out not to be an effective treatment for breast cancer.

It was tested, appeared that it might be promising, then was tested again and yet again. But, ultimately—according to the FDA—bevacizumab “does not prolong overall survival in breast cancer patients, or provide a sufficient benefit in slowing the disease progression to outweigh the significant risks to patients.”

Here’s the full story.

Bevacizumab is a cancer-fighting drug that works by blocking the blood supply to a cancer.

Original FDA approval for bevacizumab as treatment for breast cancer was granted after a carefully executed trial demonstrated that patients with metastatic breast cancer who received bevacizumab, plus a commonly used chemotherapeutic drug, paclitaxel, did better than patients who received chemotherapy without bevacizumab.

After the trial, however, there were concerns: Patients who received bevacizumab had a longer time until progression of their disease, but they did not live any longer than those who did not receive the bevacizumab.

Subsequently, three additional trials of patients with widespread breast cancer were conducted, with all of the trials comparing a chemotherapeutic agent with bevacizumab to the same agent without bevacizumab. None—that’s right, not one—of the trials demonstrated a survival benefit with the use of bevacizumab.

The bottom line?

Bevacizumab does not improve the survival of patients with metastatic breast cancer, and any benefits would be small and would have to be measured against significant toxicity to the patient, as well as cost.
As a long-time physician and cancer treatment researcher, I agree with the FDA’s conclusion. It’s time to move on and focus our efforts on the next promising treatments for breast cancer.

8/19/11