The US Food and Drug Administration (FDA) has approved bevacizumab (Avastin), used in combination with interferon alfa-2a, for the treatment of metastatic renal cell carcinoma. Roche, the drug’s manufacturer, made the announcement on August 3.
美国食品与药品监督管理局（FDA）批准贝伐单抗（Avastin）联合干扰素α-2a用于治疗转移性肾细胞癌。药物生产商，Roche于8月3日宣布了此项结果。

The approval was based on results of the randomized, double-blind, placebo-controlled phase III AVOREN study, which showed a near-doubling of progression-free survival (PFS) in patients who received bevacizumab plus interferon compared with those who received interferon alone. Median PFS was 10.2 months for the bevacizumab/interferon alfa group vs 5.4 months for the interferon alfa–alone group. This represented an 89% improvement in median PFS. The 649 patients in the AVOREN study had received no prior treatment for their advanced renal cell carcinoma.此项批准是基于随机，双盲，安慰剂对照的III期临床试验AVOREN决定的，该研究比较了患者分别接受贝伐单抗联合干扰素和单独应用干扰素的无进展生存期（PFS）的不同。贝伐单抗/干扰素组的中位PFS是10.2个月，干扰素组为5.4个月。这说明中位PFS延长了89%。AVOREN试验中649名晚期肾细胞癌患者入组之前未接受过治疗。

PFS, rather than overall survival (OS), was accepted by regulatory authorities in the United States and Europe as the endpoint for approval of bevacizumab for the renal cell carcinoma indication. No significant difference in OS between the treatment groups was noted. Median OS was 23 months in the bevacizumab/ interferon alfa group vs 21 months in the interferon alfa–alone group. A reduction in tumor size was observed in 30% of patients treated with bevacizumab plus interferon alfa compared with 12% of those treated with interferon alfa alone. Adverse events seen in this trial for bevacizumab and interferon alfa were consistent with those reported in previous trials.
欧美权威机构接受PFS作为观察终点，而非总生存期（OS），肾细胞癌作为贝伐单抗的适应症范围。两治疗组间的OS没有明显差异。贝伐单抗/干扰素组的中位OS为23个月，而干扰素组为21个月。贝伐单抗/干扰素组中30%患者肿瘤体积缩小，而干扰素组只有12%患者肿瘤体积缩小。在该试验中接受贝伐单抗和干扰素导致的副作用与此前的试验一致。

The approval of bevacizumab for renal cell carcinoma adds a fifth FDA-approved indication for the drug, which is also approved for the treatment of breast, lung, and colon cancers and glioblastoma.
FDA批准贝伐单抗用于治疗肾细胞癌，从而增加了该药的第5个适应症，还批准贝伐单抗用于治疗乳腺癌，肺癌，结肠癌和胶质母细胞瘤。

Bevacizumab blocks the action of the vascular endothelial growth factor (VEGF) receptor, a key factor in tumor angiogenesis, growth, and metastasis. Most renal cell carcinomas overexpress VEGF. Renal cell carcinoma accounts for 90% of cases of kidney cancer.贝伐单抗阻断血管内皮生长因子（VEGF）受体活性，是肿瘤血管生成，增殖和转移的重要因子。绝大多数肾细胞癌的VEGF过表达。肾细胞癌占所有肾癌病例的90%。

Bevacizumab is being studied in various tumor types at different stages. Combination therapy with everolimus, an mTOR inhibitor, is also being investigated.
在不同肿瘤类型的不同分期，研究贝伐单抗的作用。联合依维莫司，mTOR抑制剂也正处于研究中。