Roche Loses Appeal over Cancer Drug
The FDA appeals panel voted unanimously to revoke medicine, arguing that evidence showed Avastin provided minimal benefit and carried life-threatening risks for women with breast cancer.
Roche has lost its plea to the US FDA to retain the approval of Avastin for the treatment of breast cancer.
The FDA appeals panel voted unanimously to revoke medicine, arguing that evidence showed Avastin provided minimal benefit and carried life-threatening risks for women with breast cancer.
Taking the drug off the market could cut Roche sales by almost $1bn annually and jeopardise treatment for an estimated 17,000 women currently using the medicine.
Roche won US clearance for Avastin to be used as a treatment for breast cancer in 2008, based on a study showing the drug stalled cancer growth by 5.5 months.
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