Thursday, June 30, 2011

Unprecedented FDA vote declares Avastin, the world's best-selling cancer drug, UNSAFE - 30th June 2011

A shock vote has seen a panel of cancer experts rule that Avastin, the best-selling cancer drug in the world, should no longer be used in breast cancer patients.

The unprecedented vote by the Food and Drug Administration (FDA) clears the way for the government to remove its endorsement from the drug.

The advisory panel's comes less than a year after the same panel reached the same conclusion.

The six members of the FDA oncology drug panel voted unanimously that Avastin is ineffective, unsafe and should have its approval for breast cancer withdrawn.

'I think we all wanted Avastin to succeed but the reality is that these studies did not bear out that hope,' said Natalie Compagni-Portis, the lone patient representative on the panel.

The vote is not binding and FDA Commissioner Margaret Hamburg will make the final decision sometime after July 28.

The drug is approved for multiple cancers and will still be available for breast cancer, though insurers are expected to drop coverage if it loses FDA approval.

The FDA began steps to remove Avastin's breast cancer approval in December, but Roche took the rare step of appealing that decision and lobbied the agency and Congress for a second hearing.

The dramatic, contentious tone of the two-day hearing underscored the difficulty of removing an option for cancer patients, even when backed by scientific evidence. Read More