VYLOY zolbetuximab
Drug Class
Claudin 18.2 monoclonal antibodyClaudin 18.2 单克隆抗体
Mechanism
Binds to Claudin 18.2 on tumor cells, initiating antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to destroy target cells.特异性结合癌细胞表面的Claudin 18.2蛋白，激活抗体依赖的细胞介导的细胞毒性作用（ADCC）和补体依赖的细胞毒性作用（CDC）来杀伤肿瘤细胞。
Approved Indication
CLDN18.2-positive, HER2-negative locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, per its FDA approval.根据美国FDA批准，联合化疗适用于CLDN18.2阳性、HER2阴性的局部晚期不可切除或转移性胃或胃食管结合部腺癌的一线治疗。
What This Means For Patients
Vyloy is a targeted antibody treatment for patients with advanced gastric or gastroesophageal junction cancer whose tumors are CLDN18.2-positive. It marks cancer cells for destruction by the immune system, and can be accessed in Hainan Boao Lecheng.Vyloy是一种针对CLDN18.2阳性晚期胃癌或胃食管结合部腺癌患者的靶向抗体治疗药物。它通过标记肿瘤细胞使其受到免疫系统的攻击，目前可在海南博鳌乐城特许申请。
Regulatory Approvals
- FDA — approved (2024) — source
Pivotal Clinical Evidence
- SPOTLIGHT — Shitara et al., Lancet 2023 (NCT03504397) — DOI
Sources
This page provides regulatory and mechanism-of-action information for reference only. It is not medical advice, a treatment recommendation, or a guarantee of outcome. Availability is subject to individual clinical review.