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December 16, 2010 11:30 pm
Roche has launched an unusual challenge to the US drugs regulator after a demand that it withdraw its blockbuster drug Avastin as a treatment for breast cancer.
The US Food & Drug Administration formally sought a restriction in the label of authorised uses by doctors of Avastin – known generically as bevacizumab – after scrutiny of fresh data suggested the risks outweighed the benefits.
But the Swiss pharmaceutical group refused to accept the FDA’s recommendation, triggering a rarely used procedure of a fresh public hearing to make its case to keep the treatment on the market as it fights the setback to the expanding use of the drug.
The action follows close scrutiny and debate over Avastin, which has been steadily expanding uses for a range of cancers and was the pride of Genentech, the US company which Roche acquired last year.
In a separate and co-ordinated decision on Thursday, the European Medicines Agency also limited the expanded use of Avastin in combination with other drugs.
But in a split with its US counterpart, it maintained the drug’s use for breast cancer when used in combination with paclitaxel. It argued the two treatments together were justified in providing “progression free survival”, easing the use of aggressive further chemotherapy and stress in women with cancer.
The FDA, by contrast, opted for rejection of Avastin with a higher standard, that it did not with paclitaxel improve overall survival by extending patients’ lives while risking side-effects.
Some US commentators accuse the regulator of taking a decision more linked to a desire to control costs than to examine safety and efficacy.
The charge has been vigorously denied by the FDA, which had only provided a more limited initial “conditional approval” for the drug and requiring further data which has since proved negative.
Roche’s shares dipped in late trading after the rulings. Breast cancer is only one of several uses, with the primary application being for colorectal cancer.
The company stressed Avastin had been used in 800,000 patients including 80,000 for breast cancer. It said it was continuing to search for a genetic biomarker that would allow it to target the drug to patients who would respond well.
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