Avastin: The Last Word

The FDA has announced that bevacizumab (Avastin) is no longer approved for the treatment of breast cancer. The Genentech drug retains its indications for colon, lung, kidney, and brain cancer and will remain on the market.

This issue has been extensively discussed in previous entries.

Rather than rehash my opinion, I’d like to share some recent commentary from others:

If there’s a shard of hope for patients, it is that Genentech is running a new Avastin breast cancer trial, with a particular emphasis on a potential subset biomarker, the protein known as vascular endothelial growth factor A. . . Genentech would not continue to spend tens of millions of dollars and risk Dr. Pazdur’s reprisals against its other medicines if it did not see some tangible therapeutic gain.–Wall Street Journal editorial

The risks of Avastin are real, but they’re also well-understood and manageable, especially in end-stage oncology where there are no good options. The FDA’s real goal was to send a warning to the rest of the drug industry about who is in charge of drug development. The FDA withdrew Avastin’s breast cancer approval last year—leading to Genentech’s unprecedented appeal and a two-day trial in June.

In her decision denying that appeal, Dr. Hamburg concedes that there are groups of “super responders” who experience dramatic improvements when treated with Avastin. But she then says those patients don’t count because “it is not possible to determine if there is some subset of patients within the population as a whole that may have had a meaningful benefit.” Dr. Hamburg also concedes that Avastin may produce better results when used with different chemotherapies, but that those prospects haven’t been sufficiently tested…

All of this suggests that Avastin should remain on the market as one treatment alternative as knowledge about the drug grows—which is all that Genentech requested in its appeal. Looking at the same studies, the European Medicines Agency (the FDA’s continental equivalent) continues to approve Avastin for breast cancer. The National Comprehensive Cancer Network, a highly respected consortium of U.S. oncology programs, has four times reaffirmed its recommendation that Avastin is “an appropriate therapeutic option.”

“The Avastin Denial: A chillingly blunt assertion of regulatory power against a drug for breast cancer”

“More research is needed to identify what biomarker identifies our subgroup.”–Patient

“I don’t disagree with the FDA decision,” says one woman who has been on it.  “We need to have drugs that are proven to extend survival and not settle for less. Avastin never lived up to its initial promise–except for some outliers and more research is needed to identify what biomarker identifies our subgroup.”

“There’s no group of hos­pitals and doctors whose profit and livelihood, respec­tively, depends on giving Avastin to just a few people with metastatic breast cancer.”–Elaine Schattner

…What I think is that Avastin is a scapegoat of sorts, a costly drug not par­tic­u­larly worse than many others, nor better, and that helps a small minority of women with a lethal disease for reasons their doctors can’t predict or explain.

What I wonder is, iron­i­cally, because the data on Avastin were col­lected so care­fully, that its lack of effec­tiveness over a pop­u­lation of women was better-​​documented than has been the lack of evi­dence for other drugs and reg­imens. Besides, there’s no group of hos­pitals and doctors whose profit and livelihood, respec­tively, depends on giving Avastin to just a few people with metastatic breast cancer. There was just Genentech, an easy big-​​Pharma target, and a few women, pleading for con­tinued access to a drug that’s helped to keep them alive.

“I would have appreciated being patronized because at least we would have been acknowledged,” Jake H., husband of Nancy, a patient who testified at the FDA hearing

“The hearing was really frustrating in that the FDA was indifferent to our pleas,” writes Nancy, a patient who testified at the hearing. “Several of the folks on the panel were so rude during the hearing they were literally reading their Blackberries during the public testimony. As [my husband] Jake commented, ‘I would have appreciated being patronized because at least we would have been acknowledged.’ So true! We were completely ignored on the first day and treated like we were wasting their time.”

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