FDA Decision on Withdrawal of Bevacizumab’s Indication for Breast Cancer Draws Mixed Response

The US Food and Drug Administration’s decision to revoke the breast cancer indication for bevacizumab (Avastin) announced last week (http://www.theoncologynurse.com/article/fda-starts-withdrawal-process-avastins-breast-cancer-indication) has drawn mixed response from healthcare professionals and organizations involved in the care of women with breast cancer.

 

At one end of the spectrum, an editorial in the December 17, 2010 issue of The Wall Street Journal calls the decision “a tragedy for desperately ill women” and says that “although the decision was expected, that does not make it any less reprehensible.”

 

Response from Susan G. Komen for the Cure was more measured. In a statement, the organization called for continued coverage for breast cancer patients benefitting from the drug. Elizabeth Thompson, president of the organization, said, “We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it, and that the drug’s manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program.” She also called for continued development of new breast cancer treatments and research on biomarkers to identify which patients are most likely to benefit from bevacizumab.

 

The same day as the FDA announced its decision, the European Medicines Agency endorsed continued use of bevacizumab in combination with paclitaxel to treat metastatic breast cancer although it limited its use with other chemotherapies. Similarly, the United Kingdom's Committee for Medicinal Products for Human Use has “confirmed the benefits of Avastin in combination with paclitaxel” and states that “the benefits outweigh the risks and this combination remains a valuable treatment option for patients suffering with metastatic breast cancer.”

 

Read the FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm

 

Read our coverage from August:

http://www.theoncologynurse.com/article/physicians-patients-react-fda-committee-vote-against-bevacizumab-breast-cancer