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凡德他尼:全球首次批准。

Vandetanib: first global approval.

机构信息

RD Insight, Wolters Kluwer Pharma Solutions, Auckland, New Zealand.

出版信息

Drugs. 2011 Jul 9;71(10):1355-65. doi: 10.2165/11595310-000000000-00000.

DOI:10.2165/11595310-000000000-00000
PMID:21770481
Abstract

Vandetanib is an orally active antagonist of vascular endothelial growth factor (VEGF) receptor-2 (VEGFR-2), epidermal growth factor receptor (EGFR or HER1 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.

摘要

凡德他尼是一种口服活性的血管内皮生长因子受体-2(VEGFR-2)、表皮生长因子受体(EGFR 或 HER1 或 ErbB1)和 RET 激酶拮抗剂,现已获准在美国用于治疗转移性甲状腺髓样癌(MTC)。该适应证的监管申请已在欧盟和加拿大提交,其他几个国家也在进行恶性 MTC 的临床开发。凡德他尼由阿斯利康开发,也在胆管癌、乳腺癌和前列腺癌的 II 期开发中。此前,阿斯利康撤回了美国和欧盟非小细胞肺癌(NSCLC)的监管申请,并随后停止了开发。本文总结了凡德他尼开发过程中的重要里程碑,最终导致了该药在恶性 MTC 中的首次批准。

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