Epcoritamab（epcoritamab-bysp；Epkinly™；Tepkinly®）是一种经皮下注射的CD3×CD20 T细胞结合双特异性抗体，由Genmab和AbbVie共同开发，用于治疗成熟B细胞非霍奇金淋巴瘤亚型（B-NHLs），包括弥漫性大B细胞淋巴瘤（DLBCL）。Epcoritamab于2023年5月19日在美国首次获得（有条件的）批准，用于治疗复发性或难治性（R/R）DLBCL的成年患者，包括非特异性DLBCL，包括发生于温和淋巴瘤和高级别B细胞淋巴瘤的DLBCL，以及在至少进行了2线全身治疗后的高级别B细胞淋巴瘤。在其他地方，epcoritamab已获得欧盟对作为单药治疗复发性或难治性DLBCL的成人的积极意见，该意见要求至少在2线全身治疗后使用，目前正在日本进行治疗成人的复发性或难治性大B细胞淋巴瘤的2线全身治疗的监管审查中。全球范围内正在进行epcoritamab作为单药以及联合标准护理药物治疗成熟B-NHLs的临床开发。本文总结了epcoritamab发展的里程碑，导致其首次获得R/R DLBCL的批准。© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

Epcoritamab (epcoritamab-bysp; Epkinly™; Tepkinly®) is a subcutaneously administered CD3×CD20 T-cell-engaging bispecific antibody being co-developed by Genmab and AbbVie for the treatment of mature B-cell non-Hodgkin lymphoma subtypes (B-NHLs), including diffuse large B-cell lymphoma (DLBCL). Epcoritamab received its first (conditional) approval on 19 May 2023, in the USA, for the treatment of adult patients with relapsed or refractory (R/R) DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after ≥ 2 lines of systemic therapy. Elsewhere, epcoritamab has received a positive opinion in the EU as a monotherapy for the treatment of adults with R/R DLBCL after ≥ 2 lines of systemic therapy, and is currently under regulatory review in Japan for the treatment of adults with R/R large B-cell lymphoma after ≥ 2 lines of systemic therapy. Clinical development of epcoritamab as monotherapy and in combination with standard of care agents for the treatment of mature B-NHLs is ongoing globally. This article summarizes the milestones in the development of epcoritamab leading to this first approval for R/R DLBCL.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.