Avastin: Advisory panel recommends FDA to remove advanced breast cancer indication

GAITHERSBURG, Md. – In a vote of 12 to 1 a recommendation has been issued by the Oncologic Drugs Advisory Committee advisory panel that the FDA remove the advanced breast cancer indication from Avastin (bevacizumab), after two large clinical trials failed to demonstrate a clinically significant benefit of the drug, which is associated with serious side effects. When used in combination with standard chemotherapy, Avastin did not extend progression-free survival (PFS) long enough to be clinically significant in HER2-negative, metastatic breast cancer.


In 2008, the FDA granted special, fast-track approval to Genentech, manufacturer of Avastin, to begin marketing the drug for patients with metastatic breast cancer in combination with the chemotherapy agent paclitaxel. This "accelerated" approval was based on positive early findings from a large Genentech-sponsored clinical trial that found Avastin added 5.5 months PFS vs. paclitaxel alone. However, the data from two new clinical trials (AVADO, RIBBON-1) of almost 2,000 breast cancer patients that Genentech submitted to move from accelerated approval to standard approval failed to demonstrate the PFS to the extent seen in the earlier study.* The PFS in the two trials ranged from a little less than a month, to just under three months. The results failed to demonstrate that the benefits of using Avastin outweigh the potential risks, which include a small risk of death, bleeding, febrile neutropenia and hypertension.

"Survival trumps everything, and we haven't shown a survival benefit here"

- Ronald Richardson, MD, a medical oncologist at the Mayo Clinic

Genentech argued that even small gains in progression-free survival are clinically meaningful and that additional weeks where tumors don't worsen translate to improved quality of life.

The FDA usually follows the advice of its advisory committee, and if they do this time, Avastin would still be approved to treat lung, kidney, and colon cancer. Avastin is also used treat recurrent glioblastoma under accelerated approval. The FDA will make a decision by September 17, 2010.

*For details of the studies see Avastin did not improve progression-free survival in patients with breast cancer. Available at http://medwritehealthcarecommunications.blogspot.com/2010/07/avastin-did-not-improve-progression.html. Posted July 19, 2010.

Source
FDA Panel Nixes Bevacizumab for Breast Cancer. By Emily P. Walker, Washington Correspondent, MedPage Today Published: July 20, 2010. Available at http://www.medpagetoday.com/HematologyOncology/BreastCancer/21276?utm_content=Group_&utm_medium=email&impressionId=&utm_campaign=DailyHeadlines&utm_source=mSpoke&userid= Accessed July 21, 2010.