European Medicines Agency, London, United Kingdom.
Clin Cancer Res. 2011 Nov 1;17(21):6608-14. doi: 10.1158/1078-0432.CCR-11-1734. Epub 2011 Oct 5.
On June 14, 2010, the European Commission issued a conditional marketing authorization valid throughout the European Union for pazopanib for the treatment of advanced renal cell carcinoma. Pazopanib is an antineoplastic agent that inhibits multiple receptor tyrosine kinases. The recommended oral dose is 800 mg once daily. The benefit of pazopanib is an increased progression-free survival. In the pivotal trial VEG105192, the median progression-free survival was 9.2 months (95% confidence interval, 7.4-12.9) in the pazopanib arm compared with 4.2 months (95% confidence interval, 2.8-4.2) in the placebo arm. The most common side effects include diarrhea, hair color change, hypertension, nausea, fatigue, anorexia, vomiting, dysgeusia, elevated alanine aminotransferase, elevated aspartate aminotransferase, and abdominal pain. The objective of this article is to summarize the scientific review of the application that led to approval in the European Union.
2010 年 6 月 14 日，欧盟委员会有条件批准帕唑帕尼在欧盟范围内上市，用于治疗晚期肾细胞癌。帕唑帕尼是一种抗肿瘤药物，可抑制多种受体酪氨酸激酶。推荐的口服剂量为每天 800 毫克。帕唑帕尼的获益是无进展生存期延长。在关键性试验 VEG105192 中，与安慰剂组相比，帕唑帕尼组的中位无进展生存期为 9.2 个月（95%置信区间，7.4-12.9），而安慰剂组为 4.2 个月（95%置信区间，2.8-4.2）。最常见的副作用包括腹泻、头发颜色改变、高血压、恶心、疲劳、厌食、呕吐、味觉障碍、丙氨酸氨基转移酶升高、天冬氨酸氨基转移酶升高和腹痛。本文的目的是总结导致在欧盟批准的应用的科学审查。
