FDA针对用于治疗复发/难治性滤泡性淋巴瘤和复发/难治性弥漫性大B细胞淋巴瘤(DLBCL)的生物制品许可申请(BLA)发出了完整回复函(CRL)。这款药物名为odronextamab(REGN1979),是由Regeneron公司开发的双特异性抗体,旨在针对接受过2种或以上全身治疗的患者。 CRL是关于进一步评估该药物的验证性试验的注册状态的,但值得...
出于安全方面的考虑,美国FDA日前已经告知再生元暂停旗下实验性血液肿瘤药物odronextamab(REGN1979)的多项临床试验。 FDA要求再生元进一步降低3级细胞因子释放综合征(CRS)的发生率。受到此次暂停决定影响的试验包括B-NHL的1期单药治疗试验、慢性淋巴细胞白血病的中期检查以及针对几种B-NHL亚型的单药治疗测试。 FDA此项...
编译丨范东东 出于安全方面的考虑,美国FDA日前已经告知再生元暂停旗下实验性血液肿瘤药物odronextamab(REGN1979)的多项临床试验。 FDA要求再生元进一步降低3级细胞因子释放综合征(CRS)的发生率。受到此次暂停决定影响的试验包括B-NHL的1期单药治疗试验、慢性淋巴细胞白血病的中期检查以及针对几种B-NHL亚型的单药治疗测试。
US FDA orphan drug designation—odronextamab (REGN1979). 2020. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=623317. Accessed 10 Oct 2024. Regeneron Pharmaceuticals. Regeneron reports first quarter 2022 financial and operating results [media release]. 4 May...
BACKGROUND: Odronextamab (REGN1979) is a first-in-class, hinge-stabilized, fully human IgG4-based CD3 x CD20 bispecific antibody (bsAb) that has demonstrated encouraging safety, tolerability and preliminary efficacy in a first-in-human study of patients (pts) with relapsed/refractory (R/R)...
BACKGROUND: Odronextamab (REGN1979) is a first-in-class, hinge-stabilized, fully human IgG4-based CD3 x CD20 bispecific antibody (bsAb) that has demonstrated encouraging safety, tolerability and preliminary efficacy in a first-in-human study of patients (pts) with relapsed/refractory (R/R)...
The use of single-agent odronextamab (REGN1979) in a phase 1 study demonstrated a manageable safety profile and promising preliminary activity, including durable responses in heavily pretreated patients with B-cell non-Hodgkin lymphoma (NHL), supporting further clinical investigation in phas...
针对MS4A1靶点的抗体药物,CD20-CD3双特异性抗体REGN1979 (odronextamab) 在 多种B细胞NHL患者时表现出良好的效果。 别名(Alternative names) REGN-1979 靶点;物种(Specificity target name;species) CD3E[Homo sapiens] 种类(Species) Homo sapiens 受体鉴定(Receptor identification) ...
Odronextamab (REGN1979; Regeneron Pharmaceuticals) is a novel CD20xCD3 bispecific antibody with a generally manageable safety profile that has previously demonstrated consistent anti-lymphoma activity in patients with relapsed or refractory (R/R) follicular lymphoma (FL) and R/R d...
EMERGING CLINICAL ACTIVITY OF REGN1979, AN ANTI-CD20 X ANTI-CD3 BISPECIFIC ANTIBODY (AB), IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) B-CELL NON-HODGKIN LYMPHOMA (B-NHL): S868 Introduction: REGN1979 (R1979) is an anti‐CD20 x anti‐CD3 bispecific IgG4 Ab. We report updated resul...