Specifically, this guidance addresses the FDA’s current thinking regarding clinical pharmacology considerations and recommendations for bioanalytical methods, dosing strategies, dose- and...

To date, the FDA has approved a total of 14 antibody drug conjugates (ADCs) for various cancer indications. These drugs specifically target cancer cells, delivering powerful chemotherapy drugs directly to tumors while minimizing damage to healthy tissue.

As of 2024, the U.S. Food and Drug Administration (FDA) has approved a number of ADCs for the treatment of a variety of malignancies such as breast cancer, non-small cell lung cancer, and lymphoma. Each ADC locates cancer cells through its specific antibody and then releases its potent cytotoxic drug, causing cancer cell death.

2021年5月26日 · Antibody-drug conjugates (ADCs) are rapidly developing as a targeted therapy for oncology. This presentation summarizes the current advancements in optimizing ADC design...

ADC即抗体偶联药物，是指由三个关键元素组成的将有生物活性的小分子药物通过连接子连接单克隆抗体，从而精准定位肿瘤细胞释放高效细胞毒性。 这些组件中的每一个都可以使ADC之间产生很大差异，从而导致整体结构的巨大多样性，并导致ADC的药理学和临床特性的差异。 此前，科志康已发布 全球14个已上市ADC药物CMC研究要点汇总。 下面笔者将汇总FDA批准上市的ADC产品的审评信息，主要针对非临床部分及退审发补问题进行解析，供读者参考。 图片来源：网络产 …

2024年10月3日 · The growing list of FDA-approved ADCs underscores their importance in modern oncology. By combining the precision of antibodies with the potency of cytotoxic drugs, ADCs offer more effective and safer treatments for a variety of cancers.

In late September 2021, the FDA granted accelerated approval to Tivdak ® (tisotumab vedotin-tftv), deeming it the most recently approved ADC on the market. Tivdak ® , co-developed by Seagen and Genmab, is the first and only approved ADC indicated for treatment of adult patients with recurrent or metastatic cervical cancer with disease ...

2022年，FDA仅批准了1款ADC药物，即ELAHERE（Mirvetuximab soravtansine-gynx）。 该药是 华东医药股份有限公司 全资子公司杭州中美华东制药有限公司美国合作方 ImmunoGen,Inc.开发的，用于治疗 铂耐药卵巢癌 的全球首创ADC药物。

2019年10月30日 · To date, a total of 13 ADCs have been approved by the FDA, including: ado-trastuzumab emtansine (Kadcyla™), brentuximab vedotin (Adcetris™), inotuzumab ozogamicin (Besponsa™), gemtuzumab ozogamicin (Mylotarg™) , Moxetumomab pasudotox (Lumoxiti™), polatuzumab vedotin-piiq (Polivy™), Enfortumab vedotin (Padcev™), Sacituzumab ...

2025年1月17日，阿斯利康与第一三共宣布Trop2 ADC新药Datopotamab de如xtecan获得FDA批准上市，用于治疗经内分泌治疗和化疗后进展的不可手术、转移性HR+/HER2-乳腺癌，商品名为Datroway。