Oncology pharmacists, like other healthcare professionals and organizations, have had a mixed response to the US Food and Drug Administration decision to withdraw the breast cancer indication for bevacizumab (Avastin), which was announced last week. Based on our initial report (http://www.theoncologypharmacist.com/article/fda-starts-withdrawal-process-avastins-breast-cancer-indication), readers have commented on the FDA’s decision.
Laura Boehnke Michaud, PharmD, BCOP, FASHP, manager, Clinical Pharmacy Services, Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center, Houston, commented: “I applaud the FDA for acting in the best interests of patients. The questions to ask now are (1) How do we learn from this experience and move forward to positively impact patients? and (2) Why do angiogenesis inhibitors appear to lack benefit in breast cancer while improving survival in many other cancers? Those are the questions to focus on now.”
Lew Iacovelli, Oncology Pharmacy Manager, at the Moses H. Cone Health System, Greensboro, North Carolina, however questioned the FDA decision. He notes that in the online version of The Wall Street Journal there's a report that the United Kingdom's Committee for Medicinal Products for Human Use has “confirmed the benefits of Avastin in combination with paclitaxel and that the benefits outweigh the risks and this combination remains a valuable treatment option for patients suffering with metastatic breast cancer.” He asks, “How does the FDA make a decision that goes in the complete opposite direction? You have to wonder how much of this decision was related to the finances, with respect to CMMS [Centers for Medicare and Medicaid Services] reimbursement as opposed to the clinical data.”
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.
Susan G. Komen for the Cure, the world’s largest breast cancer advocacy organization, has issued a statement calling for continued access to and coverage for breast cancer patients benefitting from bevacizumab. The organization also urges research on biomarkers to identify which patients are most likely to benefit from the drug.
Read the FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm
Read our coverage from August: