Saudi Food and Drug Authority, 3292 Northern Ring Road, Al Nafel Area, Riyadh 13312-6288, Saudi Arabia.
Saudi Pharm J. 2012 Oct;20(4):381-5. doi: 10.1016/j.jsps.2011.12.001. Epub 2011 Dec 28.
On November 18, 2011, the US Food and Drug Administration (US FDA) announced that breast cancer indication for Avastin (bevacizumab) had been withdrawn after concluding that the drug has not been shown to be safe and effective for the treatment of breast cancer. The specific indication that was withdrawn was for the use of bevacizumab in metastatic breast cancer, with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. The US FDAs decision has been met with emotion and confusion among the public and health professionals. The purpose of this article is to review the regulatory history of bevacizumab for breast cancer and to examine the scientific evidence that led to the approval and subsequent withdrawal of this indication. Bevacizumab also provides the opportunity to illustrate the value of free publicly available US FDA reviews that may contain rigorously reviewed unpublished data and analyses and to contrast the decisions made in the US and Europe about bevacizumab and breast cancer.
2011 年 11 月 18 日，美国食品药品监督管理局（FDA）宣布，在得出贝伐单抗（阿瓦斯汀）用于治疗乳腺癌既不安全也无效的结论后，已撤销其乳腺癌适应证。此次撤销的具体适应证为：转移性乳腺癌中与紫杉醇联合使用，治疗既往未接受过化疗的转移性 HER2 阴性乳腺癌患者。该决定引起了公众和卫生专业人员的情绪波动和困惑。本文旨在回顾贝伐单抗治疗乳腺癌的监管历史，并研究导致其获批和随后撤销该适应证的科学证据。贝伐单抗还提供了一个机会，可以说明免费提供的美国 FDA 审查的价值，这些审查可能包含经过严格审查的未发表数据和分析，并对比美国和欧洲在贝伐单抗和乳腺癌问题上的决策。
