| 商品名称 | Breyanzi |
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| 适用类别 | Human |
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| 治疗领域 | Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms |
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| 通用名/非专利名称 | lisocabtagene maraleucel |
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| 活性成分 | CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells) |
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| 产品号 | EMEA/H/C/004731 |
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| 患者安全信息 | no |
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| 授权状态 | Authorised |
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| ATC编码 | L01 |
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| 是否额外监管 | yes |
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| 是否仿制药 | no |
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| 是否生物类似药 | no |
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| 是否附条件批准 | no |
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| 是否特殊情形 | no |
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| 是否加速审评 | no |
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| 是否罕用药 | no |
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| 批准上市日期 | 2022/04/04 |
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| 上市许可持有人/公司名称 | Bristol-Myers Squibb Pharma EEIG |
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| 人用药物治疗分组 | Antineoplastic agents |
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| 审评意见发布日期 | 2022/01/27 |
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| 决定日期 | 2023/10/11 |
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| 修订号 | 2 |
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| 适应症 | Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. |
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| 首次发布日期 | 2022/01/24 |
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| 修订日期 | 2023/10/11 |
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| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/breyanzi |
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