欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Breyanzi
适用类别Human
治疗领域Lymphoma, Large B-Cell, Diffuse;Lymphoma, Follicular;Mediastinal Neoplasms
通用名/非专利名称lisocabtagene maraleucel
活性成分lisocabtagene maraleucel
产品号EMEA/H/C/004731
患者安全信息No
许可状态Authorised
ATC编码L01XL08
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2022/04/04
上市许可开发者/申请人/持有人Bristol-Myers Squibb Pharma EEIG
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2022/01/27
欧盟委员会决定日期2025/11/21
修订号11
治疗适应症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.   Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.  Breyanzi is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.   Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. 
适用物种
兽用药物ATC编码
首次发布日期2022/01/24
最后更新日期2025/12/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/breyanzi
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