A panel of US Government advisers has ruled that Avastin (bevacizumab) should not be approved for extended use in breast cancer patients.
The experts weighed up evidence on whether the drug offers patients a meaningful improvement in their quality of life, and voted 5 to 4 against recommending approval.
The Food and Drug Administration (FDA) is not required to follow the recommendations of the team, although it usually does.
Avastin’s manufacturer Genentech had asked the FDA to approve the drug for use alongside chemotherapy in breast cancer patients who have not already taken other medications.
But FDA scientists previously said that while Avastin slows cancer progression, it does not improve lifespan overall.
Specialists had also questioned whether the drug should be approved for the new use considering the toxicity issues and side-effects associated with the treatment, which include heart attack, hypertension and blood clots.
Avastin is currently approved for patients with certain types of colon and lung cancer, and was Genentech’s second best-selling product last year with revenues of $1.7bn.
The rejection by the FDA panel is the latest blow to hit the drug, after the regulator asked the company to resubmit medical scans showing cancer progression last September. The agency will make a final decision on Avastin in February.
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