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FDA Panel Says Revoke Approval of Avastin (bevacizumab) for breast cancer

Posted Jul 24 2010 11:30pm

An advisory committee of the Food and Drug Administration (FDA) voted 12-1 to recommend revoking approval of the drug Avastin as a treatment for breast cancer, saying the drug was not helping patients. This action is a major setback for Avastin, which is now the world’s best-selling cancer drug, with global sales of about $6 billion last year. The product has at times been hailed as a near miracle, the first medicine to work by blocking the flow of blood to tumors (anti-angiogenesis drugs). Avastin, sold by Roche’s Genentech unit, will remain on the market even if the FDA follows the committee’s advice because Avastin is also permitted as a treatment for colon, lung, kidney and brain cancers. So even if the FDA does indeed take the rare move of rescinding its approval, doctors would still be able to use Avastin off-label to treat breast cancer.

This action is part of the follow-up mandated by the rapid approval process.   Rapid approval allows promising drugs to enter the market faster with the requirement that companies continue to do research on the effectiveness.   In   this case, it appears that in terms of breast cancer, there does not appear to be a major advantage in the additional use of Avastin (it is almost always used in conjunction with chemotherapy).   In this case, the system seems to be working as it should on both ends, by getting a promising product to the market quickly and then following up to be sure that the early promise is indeed realized.

QUICK POST: FDA Panel Says Revoke Approval of Avastin (bevacizumab) for breast cancer - http://benkazie.wordpress.com/2010/07/21/quick-post-fda-panel-says-revoke-approv

FDA Panel Says Revoke Approval of Avastin (bevacizumab) for Breast Cancer - http://www.associatedcontent.com/article/5616520/fda_panel_says_revoke_approval_

F.D.A. Panel Urges Limits for Avastin - http://www.nytimes.com/2010/07/21/health/policy/21avastin.html?_r=1&hpw

FDA panel says Avastin should not be marketed for breast cancer treatment - http://www.latimes.com/news/health/la-sci-avastin-20100721,0,4084979.story

Roche May Lose $1 Billion a Year on Avastin Change - http://www.bloomberg.com/news/2010-07-20/roche-s-avastin-fails-to-win-u-s-adviso

FDA Panel Says Avastin's Breast Cancer Indication Should Be Removed - http://online.wsj.com/article/SB10001424052748703724104575379392504495872.html

Panel wants Avastin withdrawn for breast cancer - http://www.google.com/hostednews/ap/article/ALeqM5hsrSyNbgEjEv8fRvLyR0cVzoJQrQD9

Briefing Information for the July 20, 2010 Meeting of the Oncologic Drugs Advisory Committee - http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Oncologic

FDA Briefing Document Oncology Drug Advisory Committee Meeting July 20, 2010 BLA STN 125085/191 and 192 Avastin® (bevacizumab) Applicant: Genentech Inc - http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs

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