欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tevimbra
适用类别Human
治疗领域Esophageal Squamous Cell Carcinoma;Carcinoma, Non-Small-Cell Lung;Small Cell Lung Carcinoma;Nasopharyngeal Carcinoma;Stomach Neoplasms
通用名/非专利名称tislelizumab
活性成分tislelizumab
产品号EMEA/H/C/005919
患者安全信息No
许可状态Authorised
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2023/09/15
上市许可开发者/申请人/持有人Beone Medicines Ireland Limited
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2023/07/20
欧盟委员会决定日期2025/10/24
修订号15
治疗适应症Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).Tevimbra in combination with pemetrexed and platinum containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC  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. Tevimbra in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab. Small Cell Lung Cancer (SCLC)Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. Gastric or gastroesophageal junction (G/GEJ) adenocarcinomaTevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).Oesophageal squamous cell carcinoma (OSCC)Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD L1 with a TAP score ≥ 5% (see section 5.1).Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy. Nasopharyngeal carcinoma (NPC)Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.
适用物种
兽用药物ATC编码
首次发布日期2023/07/17
最后更新日期2025/12/02
产品说明书https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tevimbra
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