Avastin is the world's best selling cancer drug and was thought to be the best hope for women with metastatic or widespread breast cancer.
But now, a study presented to the Food and Drug Administration (FDA) shows the results of the drug do not live up to the hype.
Oncologist, Dr. Jay Brooks, had high hopes for Avastin, saying "we as treating physicians and the public like the idea that we have new ways of treating patients with cancer and it offered hope."
But a new study, commissioned by the FDA, has doctors and patients wondering if that hope really helps.
Dr. Brooks explains that "in longer term follow up it really does not help patients like we originally thought it did."
Avastin, which is sold by Roche, quickly became the best selling cancer drug in the world, earning $6 billion in sales just last year. When the FDA agreed to fast-track the drug's approval process in 2008, it was thought to be a breakthrough in cancer treatment. That's because Avastin targets the tumor's blood supply. It's an approach researchers thought would starve the cancer and shrink the tumor.
Even before the drug's effectiveness came into question, its side effects were cause for concern.
Dr. Brooks says, "I've had patients experience those side effects, namely blood clots to their lungs. I've had one patient have a perforation of their intestines."
Of the 90 drugs fast-tracked by the FDA, only one has ever had approval withdrawn. That happened just last month when Mylotarg, a rarely used leukemia drug sold by Pfizer, had its approval pulled. And that's just what a panel advising the agency wants the FDA to do, voting 12 to one in favor of revoking approval of Avastin for the treatment of breast cancer.
The FDA will be looking closely at the drug over the next several weeks before making an official decision. Avastin is also used to treat colon, lung, kidney and brain cancers. It's effectiveness in treating breast cancer is the treatment use in question now.