Astellas Pharma Inc. announced that the FDA has approved Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

Astellas Pharma Inc.宣布，FDA已批准Vyloy（唑倍妥昔单抗clzb）联合含氟嘧啶和铂类化疗用于局部晚期不可切除或转移性人表皮生长因子受体2（HER2）阴性胃或胃食管交界处（GEJ）腺癌的一线治疗，根据FDA批准的测试，其肿瘤为claudin（CLDN）18.2阳性。

Vyloy is the first and only CLDN18.2-targeted therapy approved in the U.S.

Vyloy是美国批准的第一个也是唯一一个CLDN18.2靶向治疗。

In the SPOTLIGHT and GLOW clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive.CLDN18.2 positivity is defined as greater than 75% of tumor cells demonstrating moderate to strong membranous CLDN18 immuno-histochemical staining, as determined by the Ventana CLDN18 (43-14A) RxDx Assay from Roche.

在SPOTLIGHT和GLOW临床试验中，大约38%的筛查患者的肿瘤为CLDN18.2阳性。CLDN18.2阳性定义为超过75%的肿瘤细胞表现出中度至强烈的膜性CLDN18免疫组织化学染色，这是由罗氏的Ventana CLDN18（43-14A）RxDx测定法确定的。

Astellas collaborated with Roche on the newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients who may be eligible for Vyloy..

Astellas与Roche合作进行了新批准的免疫组织化学（IHC）伴随诊断（CDx）测试，以确定可能符合Vyloy条件的患者。。

Samuel  J. Klempner, M.D., Associate Professor, Harvard Medical School, Medical Oncologist at Massachusetts General Hospital, Boston ; 'While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the last several years, there is still a tremendous unmet need among our patients.

塞缪尔J。医学博士Klempner，哈佛医学院副教授，波士顿马萨诸塞州总医院肿瘤内科医师虽然在过去几年中，局部晚期不可切除和转移性胃癌和GEJ癌的一线治疗取得了进展，但我们的患者仍然存在巨大的未满足需求。

The approval of Vyloy based on the pivotal Phase III SPOTLIGHT and GLOW trials, brings forward a novel biomarker and new therapy for patients whose tumors are CLDN18.2 positive, and for those on the frontlines of treatment decision-making.'.

Vyloy基于关键的III期聚光灯和GLOW试验的批准，为CLDN18.2阳性肿瘤患者以及治疗决策一线的患者提出了一种新的生物标志物和新疗法。

Condition: Gastric Cancer/HER2 + /GEJ adenocarcinoma

条件：胃癌/HER2+/GEJ腺癌

Type: drug

类型：药物