First tumor-agnostic approval for an ADC

IF 50 1区 医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Nature Medicine Pub Date : 2024-12-13 DOI:10.1038/s41591-024-03389-6
Karen O’Leary
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ADC 首次获准用于肿瘤诊断
今年4月,靶向her2的抗体-药物偶联物(ADC)曲妥珠单抗德uxtecan被美国食品和药物管理局加速批准,用于治疗不可切除或转移性her2阳性实体瘤。在2019年首次批准该药物用于治疗不可切除或转移性her2阳性乳腺癌患者后,最近的肿瘤不确定批准是基于DESTINY临床试验系列的2期研究:DESTINY- pantumor02, DESTINY- lung01和DESTINY- crco2。之前在胃癌或非小细胞肺癌患者中报道了有希望的疗效数据,这导致了对这些癌症的特定批准,但最近的数据显示了许多实体肿瘤适应症的益处-包括妇科癌症,对新治疗方案的需求特别强烈。原始参考文献:FDA https://go.nature.com/4fkvDPg (2024);j .中国。中华医学杂志,42,47-58 (2024);柳叶刀肿瘤学杂志,25,439-454 (2024);柳叶刀肿瘤学杂志,25,1147-1162 (2024)
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来源期刊
Nature Medicine
Nature Medicine 医学-生化与分子生物学
CiteScore
100.90
自引率
0.70%
发文量
525
审稿时长
1 months
期刊介绍: Nature Medicine is a monthly journal publishing original peer-reviewed research in all areas of medicine. The publication focuses on originality, timeliness, interdisciplinary interest, and the impact on improving human health. In addition to research articles, Nature Medicine also publishes commissioned content such as News, Reviews, and Perspectives. This content aims to provide context for the latest advances in translational and clinical research, reaching a wide audience of M.D. and Ph.D. readers. All editorial decisions for the journal are made by a team of full-time professional editors. Nature Medicine consider all types of clinical research, including: -Case-reports and small case series -Clinical trials, whether phase 1, 2, 3 or 4 -Observational studies -Meta-analyses -Biomarker studies -Public and global health studies Nature Medicine is also committed to facilitating communication between translational and clinical researchers. As such, we consider “hybrid” studies with preclinical and translational findings reported alongside data from clinical studies.
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