The FDA made the decision to revoke Avastin’s status as a breast cancer drug when follow-up studies have shown that it has performed very poorly among patients. On top of that, the drug also carries serious side effects with it, as the risk may outweigh its potential benefits.
smartabouthealth.net
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The data discussed at the meeting Tuesday suggested that, at least for advanced breast cancer, the initial data that led to approval was not borne out by subsequent studies.
“I’m really not seeing that this has a benefit for patients,” Natalie Compagni Portis, the patient representative on the committee, said during the meeting in Gaithersburg, Md. “Hope is very important, but to offer hope that isn’t substantiated I don’t think is responsible.”
Avastin, which is sold by Roche’s Genentech unit, will remain on the market even if the F.D.A. follows the committee’s advice, as it usually does. That is because Avastin is also permitted as a treatment for colon, lung, kidney and brain cancers. So even if the F.D.A. does indeed take the rare move of rescinding its approval, doctors would still be able to use Avastin off-label to treat breast cancer.
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