| 商品名称 | Enhertu |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Breast Neoplasms |
| 通用名/非专利名称 | trastuzumab deruxtecan |
| 活性成分 | trastuzumab deruxtecan |
| 产品号 | EMEA/H/C/005124 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01FD04 |
| 是否额外监管 | Yes |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | No |
| 是否附条件批准 | Yes |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2021/01/18 |
| 上市许可开发者/申请人/持有人 | Daiichi Sankyo Europe GmbH |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2020/12/10 |
| 欧盟委员会决定日期 | 2025/11/21 |
| 修订号 | 19 |
| 治疗适应症 | Breast cancerHER2-positive breast cancerEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.HER2-low and HER2-ultralow breast cancerEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1). HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2). Non-small cell lung cancer (NSCLC)Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.Gastric cancer Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/02/08 |
| 最后更新日期 | 2025/12/03 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/enhertu |