| 商品名称 | Tizveni |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Carcinoma, Non-Small-Cell Lung |
| 通用名/非专利名称 | tislelizumab |
| 活性成分 | tislelizumab |
| 产品号 | EMEA/H/C/005542 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | L01FF09 |
| 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 | No |
| 上市许可日期 | 2024/04/19 |
| 上市许可开发者/申请人/持有人 | BeiGene Ireland Ltd |
| 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 | 2024/02/22 |
| 修订号 | |
| 治疗适应症 | Non-small cell lung cancer (NSCLC)Tizveni in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have:• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or• metastatic NSCLC.Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have:• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or• metastatic NSCLC.Tizveni as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/02/23 |
| 最后更新日期 | 2024/08/02 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tizveni-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tizveni |