Type of information: Withdrawal of the product
Product name: Avastin®
Therapeutic area: Cancer - Oncology
Action mechanism: monoclonal antibody. Avastin® is an antibody that precisely targets and inhibits vascular endothelial growth factor (VEGF)for continuous tumour control. Avastin’s VEGF inhibition allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.
Company: Roche (Switzerland)
Disease: first-line treatment in combination with capecitabine of patients with metastatic breast cancer in whom treatment with other chemotherapy options, including taxanes or anthracyclines, is not considered appropriate.
- • On November 18, 2011, the FDA announced that it has revoked its approval of the breast cancer indication for Avastin® (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use. Avastin® will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme). This decision involves Avastin® used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from Avastin®’s product labeling. Avastin® was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval.
- After the accelerated approval of Avastin® for breast cancer, the drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug. FDA’s Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.
- Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a decision to be made by the Commissioner. That two-day hearing, which took place June 28-29, 2011, included recommendations from the FDA's Oncologic Drugs Advisory Committee (ODAC), voting 6-0 in favor of withdrawing approval of Avastin®’s breast cancer indication. After the hearing, the public docket remained open until Aug. 4, 2011.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE: 2011-04-14
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
Is general: Yes