NCCN PK FDA：Avastin治疗乳腺癌的存废之争

2011-08-03 MedSci原创 MedSci原创

今年1月，在专家组全票支持的情况下，FDA撤销了Avastin联合紫杉醇化疗一线治疗HER2阴性转移性乳腺癌的适应症。而7月30日，NCCN专家组却全票（24票对0票，1票弃权）支持在转移性乳腺癌治疗指南中保留Avastin。各方表现颇值得玩味。同时欧盟European Medicines Agency（EMA）仍然保持了Avastin联合紫杉醇化疗一线治疗HER2阴性转移性乳腺癌的适应症。

今年1月，在专家组全票支持的情况下，FDA撤销了Avastin联合紫杉醇化疗一线治疗HER2阴性转移性乳腺癌的适应症。而7月30日，NCCN专家组却全票（24票对0票，1票弃权）支持在转移性乳腺癌治疗指南中保留Avastin。各方表现颇值得玩味。

同时欧盟European Medicines Agency（EMA）仍然保持了Avastin联合紫杉醇化疗一线治疗HER2阴性转移性乳腺癌的适应症。

为什么两个不同的专家组有完全相反的结论？FDA之所以要撤销了Avastin的适应症，是因为后续研究发现Avastin并不增加患者的总生存期（OS）。而NCCN则认为，虽然Avastin化疗方案不能增加患者总生存期，但是却显著改善了无进展生存！对患者有益。

分析人士认为，其中可能还有更深的背景。实际上乳腺癌患者每年使用Avastin大约要花费8-9万美元，这是相当一笔费用，对于经济并不景气的美国政府来说，是不小的负担。相反，在NCCN中，共有33位成员，其中10位，包括NCCN主席，都来自于Genentech/Roche，即Avastin的生产商。因此，作为NCCN不愿意放弃Avastin可能带来的利益。

不过，在FDA撤消Avastin用于晚期转移性乳腺癌的适应症后，人们担心医疗保险公司也将不再为患者支付这笔额外的费用。但是美国重要的医疗保险公司Medicare 宣布，虽然FDA撤消Avastin的这一适应症，他们仍然乐意为患者提供医疗保险支付！

MedSci认为，这其中涉及到FDA，保险公司，NCCN，罗氏这四家的利益之争。相信，这一搏弈还将继续。

参考资料：

1. U.S. Food and Drug Administration: FDA begins process to remove breast cancer indication from Avastin label. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm? Accessed January 3, 2011.

2. European Medicines Agency: European Medicines Agency completes its review of Avastin used in breast cancer. Available at www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/12/news_detail_001166.jsp. Accessed January 3, 2011.

3 NCCN decides to maintain bevacizumab use in metastatic breast cancer. http://journals.lww.com/oncotimesuk/Fulltext/2011/05000/NCCN_decides_to_maintain_bevacizumab_use_in.9.aspx

4 NCCN Backs Avastin for Breast Cancer. http://www.breastcancer.org/treatment/targeted_therapies/new_research/20110727.jsp

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2014-05-10 pharmk394

Very nice site!

172 0
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2014-05-10 pharma537

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217 0
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2014-05-10 pharmb791

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148 0
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2014-04-27 pharmg845

Very nice site!

164 0
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2014-04-27 pharme679

Very nice site!

211 0
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2014-04-27 pharmd612

Very nice site!

143 0
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2014-04-25 pharmg972

Very nice site!

168 0
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2014-04-25 pharmk628

Very nice site!

169 0
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2014-04-23 pharmb594

Very nice site!

142 0
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2014-04-22 pharmb522

Very nice site!

100 0

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