美国食品药物管理局（FDA）已经核准bevacizumab静脉输注剂（Avastin，Genetech药厂）的新适应症，用於治疗转移性肾细胞肾癌。建议剂量为每两週注射10 mg/kg，合併干扰素α-2a（每週三次皮下注射9 MIU）。
Bevacizumab是一个透过与血管内皮细胞生长因子结合的单株抗体，因此可以抑制血管新生。抑制血管新生会使肿瘤丧失血液、氧气以及其他维持肿瘤生长与转移的营养物质。
肾臟癌症学会执行主任William P. Bro在一家公司新闻稿中表示，我们希望研究团队有一天发现治癒肾臟癌症的方法。直到那时候，每个新药都提供病患一个发现最适合他们治疗的机会。
这项适应症的核准主要是根据一项全球性、随机分派、双盲、安慰剂控制第三期研究，称为the Avastin in Renal（简称AVOREN）研究，这项研究收纳了649位新诊断罹患转移性肾癌患者，证实干扰素α-2a加上bevacizumab，相较於仅使用干扰素α-2a，显著增加免於恶化存活率达67%（10.2个月相较於5.4个月；危险比值[HR]为0.60；95%信赖区间[CI]为0.49-0.72）。
研究结果显示，相较於仅使用干扰素α-2a的12%，合併治疗显著降低肿瘤大小达30%。然而，在发生444件死亡事件后的最终分析，整体存活率中位数并没有改善（存活时间，23个月相较於21个月；HR为0.86；95% CI为0.72-1.04）。
这项研究中通报的不良反应事件与bevacizumab及干扰素α-2a的安全性资料相符，最常报告的包括疲倦（13%）、虚弱（10%）、蛋白尿（7%）、高血压（6%）与出血（3%）。
Bevacizumab过去被核准用於转移性大肠直肠癌、非扁皮细胞非小细胞肺癌、转移性乳癌与神经胶母细胞瘤。

FDA Approves Bevacizumab for Treatment of Metastatic Renal Cell Carcinoma
August 4, 2009 — The US Food and Drug Administration (FDA) has approved a new indication for bevacizumab intravenous infusion (Avastin, Genentech, Inc) for the treatment of metastatic renal cell carcinoma. The recommended dose is 10 mg/kg every 2 weeks in combination with interferon α-2a (9 MIU subcutaneously 3 times weekly).
Bevacizumab is a monoclonal antibody that works by binding to vascular endothelial growth factor and preventing its role in angiogenesis, which deprives tumors of blood, oxygen, and other nutrients necessary to support their growth and metastasis.
\"We hope that researchers someday find a cure for kidney cancer,\" said William P. Bro, chief executive officer of the Kidney Cancer Association in a company news release. \"Until then, each new medicine...offers patients an opportunity to find a treatment best suited for them.\"
Approval of the indication was based on data from a global, randomized, double-blind, placebo-controlled phase 3 study — the Avastin in Renal (AVOREN) study — of 649 patients with newly diagnosed metastatic renal cell carcinoma, showing that the addition of bevacizumab to interferon α-2a significantly increased progression-free survival by 67% compared with interferon α-2a alone (10.2 months vs 5.4 months; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.49 – 0.72).
Results also showed that the combination therapy significantly decreased tumor size by 30% compared with 12% for interferon α-2a alone. However, no improvements were observed in median overall survival on the final analysis after 444 deaths (survival, 23 months vs 21 months; HR, 0.86; 95% CI, 0.72 – 1.04).
Adverse events reported in the study were consistent with the safety profiles for bevacizumab and interferon α-2a, with fatigue (13%), weakness (10%), proteinuria (7%), hypertension (6%), and bleeding (3%) most often reported.
Bevacizumab previously was approved for the treatment of metastatic colorectal cancer, nonsquamous non-small cell lung cancer, metastatic breast cancer, and glioblastoma.