FDA Panel Rules Against Avastin - Again

Avastin may no longer be approved for metastatic breast cancer

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) In an unprecedented appeals hearing, the US Food and Drug Administration (FDA) has not changed its mind.  An FDA panel voted that the drug Avastin no longer be approved for treating late-stage breast cancers.

A panel of federal cancer experts made the ruling against one of the best-selling cancer drugs in the world. They concluded that the medication is not effective against usually fatal forms of breast cancer and has too many dangerous side effects.

"FDA panel votes against approving Avastin for treating advanced breast cancers."

The FDA announced the same ruling in December 2010 after four clincial trials concluded that the drug did not extend patient lives.

The drug's manufacturer, Genetech - a division of Roche - appealed that decision that was reconsidered during the two-day hearing which saw emotional testimony from both physicians and breast cancer survivors.

It was a unanimous 6-0 vote, which isn't actually binding. The FDA commission will make the final decision.

Avastin is approved for a number of cancers, including metastatic colorectal, nonsquamous non-small cell lung cancer, metastatic renal cell carcinoma, and can still be used as a breast cancer treatment, even if FDA approval is removed.

Reviewed by: 
Review Date: 
June 29, 2011
Last Updated:
July 5, 2013