FDA moves against Avastin
Although not unexpected, the FDA's decision this week to remove breast cancer as an indication for the use of Avastin has stimulated a large and loud response. The studies are quite clear and convincing that Avastin does not improve survival for women with Stage IV breast cancer and may cause a number of very serious side effects. There are ongoing clinical trials studying the value of Avastin in the adjuvant setting, and this decision will not impact those studies.
There are some women with metastatic breast cancer who seemingly are being helped by Avastin. Note the "seemingly" because there is never a way to be certain that someone's doing well is directly related to a single drug rather than other ongoing treatments or factors. These women, however, are understandably outraged and terrified by the FDA's decision. Can their doctors continue to prescribe Avastin to them "off-label"? Yes. But, and this is a big "but", their insurance companies may refuse to pay for it and the cost of this drug is thousands of dollars per month.
Here is a quote from MedPage and a link to read more:
FDA Moves to Drop Avastin Breast Cancer Indication
WASHINGTON -- The FDA has begun the process of removing the breast cancer indication for bevacizumab (Avastin).
Citing a lack of evidence of safety and effectiveness from four clinical trials, the agency decided that "the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients."
The decision follows an FDA advisory committee's 12-1 vote in July to recommend removal of the indication for metastatic breast cancer
At a news briefing to announce the decision, Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, offered a bottom-line assessment about the rationale for seeking to remove the breast cancer indication.
"None of the four trials showed any survival benefit," said Woodcock. "They did not show that adding Avastin to a variety of chemotherapy regimens prolongs the life of women with metastatic breast cancer, but added many serious side effects."