[Expert consensus on amivantamab clinical application and adverse reaction management (2025 edition)].

Abstract

Amivantamab is the first fully humanized bispecific antibody approved for the treatment of non-small cell lung cancer (NSCLC) in the world. Amivantamab can block epidermal growth factor receptor (EGFR) pathway and mesenchymal-epithelial transformation factor (MET) pathway simultaneously, trigger the internalization and degradation of EGFR and MET, and activate the antitumor immune response. Amivantamab has been approved by the National Medical Products Administration for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation, EGFR exon 19 deletion or exon 21 L858R substitution mutation, and is expected to be widely used in clinical practice soon. How to reasonably manage the adverse reactions related to amivantamab and maximize its efficacy is an urgent problem to be solved. Based on the existing medical evidence, combined with clinical experience, the expert group of this consensus finally formulated this "Expert consensus on amivantamab clinical application and adverse reaction management (2025 edition)" after multiple discussions. The contents of the consensus include the clinical use and management of adverse reactions of amivantamab. The recommendations focus on the prevention of infusion-related reactions, skin adverse reactions, venous thromboembolism, peripheral edema, oral mucositis, ocular toxicity and interstitial lung disease, amivantamab dose adjustment and treatment when adverse events occur, in order to provide guidance for clinicians to correctly use amivantamab and manage related adverse reactions.

埃万妥单抗是全球首个获批用于非小细胞肺癌（NSCLC）治疗的全人源化双特异性抗体，通过同时阻断表皮生长因子受体（EGFR）通路和间质-上皮转化因子（MET）通路、介导EGFR和MET的内化和降解并激活免疫反应起到抗肿瘤作用，目前已被批准用于治疗携带EGFR 20号外显子插入突变、EGFR 19号外显子缺失或21号外显子L858R置换突变的局部晚期或转移性NSCLC成人患者，且未来预期会有更多的适应证获批。如何在临床上正确使用埃万妥单抗，使其在充分发挥疗效的同时亦管理好该药物相关的不良反应是目前亟需解决的问题。埃万妥单抗临床使用及不良反应管理共识专家组基于现有的循证医学证据，结合临床实践经验，经过多次研讨，最终制定了《埃万妥单抗临床使用及不良反应管理专家共识（2025版）》。共识内容包括埃万妥单抗的临床使用和不良反应的管理，重点对输液相关反应、皮肤相关不良反应、静脉血栓栓塞症、外周水肿、口腔黏膜炎、眼部不良反应和间质性肺疾病的预防、发生不良反应时的剂量调整和治疗进行了建议，旨在为临床正确使用埃万妥单抗和管理相关不良反应提供指导。.