Vandetanib First Global Approval
Vandetanib First Global Approval
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DOI：
10.2165/11595310-000000000-00000
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发表时间：
2011-01-01
期刊：
影响因子：
11.5
通讯作者：
Perry, Caroline
中科院分区：
文献类型：
--
作者：
Commander, Helen;Whiteside, Glenn;Perry, Caroline
Vandetanib是血管内皮生长因子受体-2(VEGFR-2)、表皮生长因子受体(EGFR或HER I或ErbB1)和RET激酶的口服活性拮抗剂，目前在美国用于治疗转移性甲状腺髓样癌(MTC)。欧盟和加拿大已经提交了关于这一适应症的监管文件，其他几个国家正在进行恶性MTC的临床开发。Vandetanib由阿斯利康公司开发，也处于治疗胆道癌、乳腺癌和前列腺癌的II期开发阶段。早些时候，阿斯利康撤回了美国和欧盟对非小细胞肺癌(NSCLC)的监管申请，后来停止了开发。这篇文章总结了范德丹尼开发的里程碑，导致了这一首次批准用于恶性MTC。
Vandetanib is an orally active antagonist of vascular endothelial growth factor (VEGF) receptor-2 (VEGFR-2), epidermal growth factor receptor (EGFR or HER I or ErbB1) and RET kinase, and is now available in the US for the treatment of metastatic medullary thyroid cancer (MTC). Regulatory submissions for this indication have been filed in the EU and Canada, with clinical development in malignant MTC ongoing in several other countries. Vandetanib is being developed by AstraZeneca, and is also in phase II development for biliary, breast and prostate cancer. Earlier, AstraZeneca withdrew regulatory filings for non-small cell lung cancer (NSCLC) in the US and EU, and later discontinued development. This article summarizes the milestones in the development of vandetanib leading to this first approval in malignant MTC.