New trials have shown that the cancer drug Avastin offers no benefit in the treatment of breast cancer.
The results led an advisory committee for the Food and Drug Administration to recommend the US agency withdraw marketing approval for the drug in breast cancer treatment.
If the recommendation were to be carried out, Roche would not be able to use breast-cancer related marketing for the drug.
However, the company would be able to continue marketing the drug for brain, lung, colon and kidney cancer.
The initial approval was based on trials which combined Avastin with the breast cancer drug paclitaxel in women with metastatic breast cancer.
They showed that when the drugs were combined the time during which therapy prevented the disease’s progression was increased.
This period, known as progression-free survival, was up more than five months compared with paclitaxel alone.
However, the combination did not lead to a significant increase in overall survival.
The drug’s manufacturer, Roche subsidiary Genentech, said in a statement that it supported the data it gave to the FDA.
The agency is expected to make a decision by September 17.
Copyright Press Association 2010