ROCKVILLE, Md. -- The Food and Drug Administration on Nov. 18 revoked approval for Avastin to treat breast cancer after concluding that the drug did not slow progression of tumors and that any benefits did not outweigh the drug's risks.
(Decision. Document #28-111201-001X.)
In 2008, the FDA granted fast-track approval of Avastin (bevacizumab), in combination with the cancer drug paclitaxel, to treat a metastatic breast cancer known as HER-2 negative. The approval was for women who were not treated with chemotherapy for HER-2 negative breast cancer.
Manufacturer Genentech, which was subsequently acquired by Swiss drug maker F. Hoffman-La Roche Inc., was required to conduct two post-approval studies. The FDA said those studies showed only a small effect on slowing tumor growth and showed no evidence that patients lived any longer or had a better quality of life when compared to standard chemotherapy alone.
The FDA said Avastin's small effect on tumor growth was "not enough to outweigh the risk of taking the drug."
In a press release, FDA Commissioner Dr. Margaret Hamburg said, "After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life."
The FDA said Avastin's risks include high blood pressure, bleeding and hemorrhaging, heart attack, heart failure and the development of perforations in various parts of the body, including the nose, stomach and intestines. "These are considerable risks of taking Avastin and can be justified only if there is a good evidence that the use of the drug will benefit the patient," the FDA said in a question-and-answer document.
The FDA's Center for Drug Evaluation and Research (CDER) ultimately concluded that the results of Genentech's studies did not justify continued approval for breast cancer and notified Genentech of its decision.
Genentech, the FDA said, did not agree with CDER's evaluation of the data and asked for a hearing. After a two-day advisory hearing in June, the FDA's Oncologic Drugs Advisory Committee voted 6-0 to recommend withdrawing Avastin's breast cancer approval.
In her 70-page decision, Hamburg said the Avastin breast cancer approval decision was not based on a showing that Avastin helped patients live longer or improved their quality of life. Instead, she said fast-track approval was based on "progression-free survival" (PFS), which measures whether the tumor's size increases.
At the time of the approval, Hamburg said there was evidence that there was a 5.5-month increase in the median PFS, which was statistically significant. She said that was not borne out by subsequent study.
The FDA said Avastin remains approved to treat colon, lung, kidney and brain cancer.
According to Roche, Avastin has annual sales of $3.3 billion.
In a press release, Genentech said it will start a new trial of Avastin and paclitaxel for the treatment of metastatic breast cancer. It also said it will continue to provide help through its patient support programs "to those who may be facing obstacles to receiving their treatment in the United States."
During its press conference announcing the revocation, the FDA acknowledged that its decision may mean that health insurers will no longer pay for Avastin for breast cancer. It also said its decision does not affect doctors' decision to prescribe Avastin as they see fit.
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