| 商品名称 | Blincyto |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| 通用名/非专利名称 | blinatumomab |
| 活性成分 | blinatumomab |
| 产品号 | EMEA/H/C/003731 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01FX07 |
| 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 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | Yes |
| 上市许可日期 | 2015/11/23 |
| 上市许可开发者/申请人/持有人 | Amgen Europe B.V. |
| 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 | 2015/09/24 |
| 欧盟委员会决定日期 | 2025/06/19 |
| 修订号 | 24 |
| 治疗适应症 | Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B‑cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2). Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/18 |
| 最后更新日期 | 2025/07/23 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/blincyto |