EMA and FDA prune the checkpoint inhibitor treatment landscape

Teo Min Yuen; Rosenberg Jonathan E.

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EMA and FDA prune the checkpoint inhibitor treatment landscape

机译：EMA和FDA修剪检查点抑制剂治疗景观

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The European Medicines Agency (EMA) and FDA have recently restricted the indications for first-line pembrolizumab and atezolizumab to patients with programmed cell death 1 ligand 1 (PD-L1)-high advanced urothelial carcinoma, a decision made following interim analyses from the ongoing Keynote-361 and IMvigor130 phase III trials. Questions remain on the magnitude of inferior survival and standardized implementation of PD-L1 testing.

机译：欧洲药物局（EMA）和FDA最近限制了一线Pembrolizumab和atezolizumab的适应症，对编程的细胞死亡1配体1（PD-L1） - 高级尿路上皮癌患者，在持续的临时分析后作出的决定 Keynote-361和IMVigor130期III试验。问题仍然存在于劣质存活率和标准化的PD-L1测试的规模上。

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《Nature reviews. Urology》 |2018年第10期|共3页
作者
Teo Min Yuen; Rosenberg Jonathan E.;
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作者单位

Mem Sloan Kettering Canc Ctr Dept Med Div Solid Tumor Oncol Genitourinary Oncol Serv New York;

Mem Sloan Kettering Canc Ctr Dept Med Div Solid Tumor Oncol Genitourinary Oncol Serv New York;

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正文语种 eng
中图分类泌尿科学（泌尿生殖系疾病）;
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1. EMA and FDA prune the checkpoint inhibitor treatment landscape [J] . Teo Min Yuen, Rosenberg Jonathan E. Nature reviews. Urology . 2018,第10期

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2. Immune checkpoint blockade therapy for cancer: An overview of FDA-approved immune checkpoint inhibitors [J] . Kristian M. Hargadon, Coleman E. Johnson, Corey J. Williams International immunopharmacology . 2018,第期

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3. Previous Immune Checkpoint Inhibitor Treatment to Increase the Efficacy of Docetaxel and Ramucirumab Combination ChemotherapyPrevious Immune Checkpoint Inhibitor Treatment to Increase the Efficacy of Docetaxel and Ramucirumab Combination Chemotherapy [J] . Harada Daijiro, Takata Kenji, Mori Shunta, Anticancer Research: International Journal of Cancer Research and Treatment . 2019,第9期

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4. Re-purposing FDA Approved Drugs: LC-HRMS Characterization of Metabolites of Drugs that Inhibit Cancer Cell Growth [C] . Samantha M. Mahmoud, Dil Ramanathan American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics . 2011

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5. Immune-Related Adverse Events in Cancer Patients Being Treated with Immune Checkpoint Inhibitors [D] . Byrne, Margaret M. 2021

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6. The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA [O] . Ioana Gherghescu, M. Begoña Delgado-Charro 2021

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7. P84 Pediatric oncology studies triggered by the united states (US) food and drug administration (FDA) and the european union (EU) european medicines agency (EMA) aim at labels, not at improved treatment. Some harm young patients by exposing them to substandard monotherapy instead of combination treatment [O] . K Rose 2019

机译：由美国（美国）食品和药物管理局（FDA）和欧洲联盟（欧盟）欧洲药物局（EMA）瞄准标签，而不是改善治疗的欧洲药物和药物肿瘤学研究。一些伤害年轻患者通过将它们暴露于不合标准的单疗法而不是组合治疗

EMA and FDA prune the checkpoint inhibitor treatment landscape

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