摘要
坦昔妥单抗是一款靶向CD19的人源化单克隆抗体,分别于2020年、2021年、2022年和2025年获美国食品药品监督管理局、欧洲药品管理局、中国香港药剂业及毒药管理局及中国国家药品监督管理局批准与来那度胺联合用于治疗不适合自体造血干细胞移植的复发难治弥漫大B细胞淋巴瘤(DLBCL)成年患者。目前,多项临床研究显示坦昔妥单抗在DLBCL、滤泡性淋巴瘤等B细胞淋巴瘤中均展现出良好的疗效,可明显改善患者预后。坦昔妥单抗治疗期间安全性良好,常见不良反应包括骨髓抑制、输液相关反应和感染等,可预防性使用粒细胞集落刺激因子或抗组胺受体药物等。为进一步规范坦昔妥单抗在B细胞淋巴瘤治疗中的临床应用,专家组成员结合坦昔妥单抗最新临床研究数据,制定了本指导原则,以供临床参考。
Tafasitamab is a humanized monoclonal antibody targeting CD19,which has been approved by the U.S.Food and Drug Administration in 2020,the European Medicines Agency in 2021,the Pharmacy&Poisons Board of Hong Kong,China in 2022,and the National Medical Products Administration in 2025 for use in combination with lenalidomide to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma(DLBCL)who are not candidates for autologous stem cell transplantation.Currently,multiple clinical studies have demonstrated that tafasitamab exhibits promising efficacy in B-cell lymphomas such as DLBCL and follicular lymphoma,significantly improving the prognosis of patients.The safety profile of tafasitamab during treatment was favorable,and common adverse events included myelosuppression,infusion-related reactions,and infections,etc.Prophylactic use of granulocyte colony-stimulating factor or antihistamines may be considered.In order to standardize the clinical application of tafasitamab in the treatment of B-cell lymphomas,an expert panel has formulated this set of guiding principles based on the latest clinical research data of tafasitamab,providing a reference for clinical practice.
作者
中国临床肿瘤学会(CSCO)淋巴瘤专家委员会
马军
赵东陆
Lymphoma Expert Committee of Chinese Society of Clinical Oncology(CSCO);Ma Jun;Zhao Donglu(不详;Harbin Institute of Hematology and Oncology,Harbin 150010,China)
出处
《白血病.淋巴瘤》
2025年第6期321-328,共8页
Journal of Leukemia & Lymphoma
