| 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 |
| 授权状态 | Authorised |
| ATC编码 | L01FD04 |
| 是否额外监管 | yes |
| 是否仿制药 | 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 |
| 批准上市日期 | 2021/01/18 |
| 上市许可持有人/公司名称 | Daiichi Sankyo Europe GmbH |
| 人用药物治疗分组 | Antineoplastic agents |
| 审评意见发布日期 | 2020/12/10 |
| 决定日期 | 2023/10/18 |
| 修订号 | 13 |
| 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 breast cancerEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic 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 cancerEnhertu 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. |
| 首次发布日期 | 2021/02/08 |
| 修订日期 | 2023/11/29 |
| 产品信息 | 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 |