Approval for Roche’s Avastin may be Withdrawn

Swiss healthcare giant Roche could receive a big blow on Friday with US and European health regulators expected to cancel the approval of its breast cancer drug Avastin. While Avastin has been approved to contain cancer fighting capabilities, recent studies have shown that the drug neither extends the survival period nor improves the symptoms among women with breast cancer.

The US Food and Drug Administration (FDA) is mulling the cancellation of its approval of the expensive drug while European agencies are also likely to follow the same path when their monthly meeting of experts ends on Thursday.

While Avastin’s approval for bowel, lung, brain and kidney cancers is not affected, experts suggest that removal of the breast cancer approval may shave off as much as $1 billion in sales of the drug.

Fran Visco, the president of the National Breast Cancer Coalition, has urged the agencies to cancel the approval saying, “If meaningful benefit cannot be established for a cancer therapy, particularly one with serious side effects, drug approval must be revoked in order for trust in the regulatory system to be maintained.”




Source-Medindia