FDA Pulls Breast Cancer Indication for Avastin

An FDA panel reviewing the efficacy of Roche’s blockbuster cancer drug Avastin in metastatic HER2 negative breast cancer has ruled to pull the indication. The vote took place Wednesday with the Advisory panel made up of cancer specialists voting unanimously to pull the indication. The panel voted three times, and each time the vote was unanimous, ruling that the data on Avastin in this particular group of breast cancer patients is not effective, and not necessarily safe, and therefore should not be approved for treatment.

In a report by the Associated Press for MSNBC.com, Natalie Compagni-Portis, the lone patient representative on the FDA panel, said "I think we all wanted Avastin to succeed but the reality is that these studies did not bear out that hope.”

Notably, the panel’s vote is not binding, and FDA Commissioner Margaret Hamburg will make the final decision.

Avastin is currently approved for treatment of several cancers, and the FDA ruling will not affect these indications.

FDA Pulls Breast Cancer Indication for Avastin

Avastin Legal Help

ADD YOUR COMMENT ON THIS STORY