An Astellas Pharma drug designed to address a novel target has landed a highly anticipated FDA approval for a rare type of gastrointestinal cancer, making it the first therapy in a new class of oncology drugs.

阿斯特拉斯制药公司（Astellas Pharma）一种旨在解决一种新靶点的药物获得了备受期待的FDA批准，用于治疗一种罕见的胃肠道癌症，使其成为新型肿瘤药物的第一种治疗方法。

The regulatory decision announced Friday covers the first-line treatment of adults with advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma. These cancers must express the cancer protein claudin 18.2 (CLDN18.2), the target of the Astellas antibody, zolbetuximab. The Japanese pharmaceutical company will market the new drug under the brand name Vyloy..

周五宣布的监管决定涵盖了晚期胃或胃食管交界处（GEJ）腺癌成人的一线治疗。这些癌症必须表达癌蛋白claudin 18.2（CLDN18.2），这是Astellas抗体zolbetuximab的靶标。这家日本制药公司将以Vyloy品牌销售这种新药。。

GEJ adenocarcinoma is a type of cancer in the area where the esophagus joins the stomach. According to Astellas, an estimated 130,263 in the U.S. people are living with gastric or GEJ cancer, which places it among the rarer cancers. CLDN18.2 is found only in stomach cells, not other healthy tissues.

GEJ腺癌是食管与胃连接区域的一种癌症。据Astellas称，估计美国有130263人患有胃癌或GEJ癌，这使其成为罕见的癌症之一。CLDN18.2仅存在于胃细胞中，而不存在于其他健康组织中。

In gastrointestinal cancers, this protein is overexpressed, making it a valuable target for cancer drugs. Vyloy binds to CLDN18.2, activating two immune system pathways that kill cells expressing the target protein..

在胃肠道癌症中，这种蛋白质过表达，使其成为抗癌药物的有价值的靶标。Vyloy与CLDN18.2结合，激活两种免疫系统途径，杀死表达靶蛋白的细胞。。

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The Promise of Value-Based Care and MedTech Innovation

基于价值的护理和医疗技术创新的承诺

Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care.

mHUB MedTech加速器的执行董事莫妮卡·瓦贾尼（MonicaVajani）讨论了mHUB如何帮助创新者将医疗保健转变为基于价值的护理。

By Monica Vajani - mHUB

作者：莫妮卡·瓦贾尼-mHUB

FDA approval of Vyloy covers the treatment of gastric or GEJ cancers that are negative for a different cancer protein called HER2. That’s important because cancers positive for HER2 already have treatment options, such as Roche’s HER2-binding antibody, Herceptin, and the AstraZeneca and Daiichi Sankyo antibody drug conjugate Enhertu.

FDA对Vyloy的批准涵盖了对另一种称为HER2的癌蛋白阴性的胃癌或GEJ癌的治疗。这一点很重要，因为HER2阳性的癌症已经有了治疗选择，例如罗氏的HER2结合抗体，赫赛汀，阿斯利康和第一三共抗体药物偶联物Enhertu。

Vyloy’s approval gives HER2-negative gastric and GEJ cancers patients a targeted treatment option for use in combination with standard of care chemotherapies..

Vyloy的批准为HER2阴性胃癌和GEJ癌症患者提供了一种靶向治疗选择，可与标准护理化疗联合使用。。

Astellas’s submission for Vyloy was based on results from two Phase 3 clinical trials that enrolled participants with advanced HER2-negative gastric or GEJ cancer that was positive for CLDN18.2. One study evaluated Vyloy in combination with the chemotherapy regimen known as FOLFOX6, comparing it to a placebo and FOLFOX6; the other trial tested the study drug and the chemo regimen known as CAPOX against a placebo and CAPOX..

Astellas提交给Vyloy的报告是基于两项3期临床试验的结果，这些试验招募了CLDN18.2阳性的晚期HER2阴性胃癌或GEJ癌患者。一项研究评估了Vyloy联合称为FOLFOX6的化疗方案，将其与安慰剂和FOLFOX6进行比较；另一项试验测试了研究药物和称为CAPOX的化疗方案与安慰剂和CAPOX的对比。。

In both studies, the combination of Vyloy and chemo led to statistically significant improvement on the main goal of progression-free survival. The studies also achieved statistically significant improvement on the key secondary goal of overall survival. The most common side effects reported in these studies included nausea, vomiting, and decreased appetite.

在这两项研究中，Vyloy和chemo的结合导致无进展生存的主要目标在统计学上显着改善。这些研究还对总体生存的关键次要目标取得了统计学上的显着改善。这些研究中报道的最常见的副作用包括恶心，呕吐和食欲下降。

In Astellas’s announcement of Vyloy’s approval, Dr. Samuel Klempner, associate professor at Harvard Medical School and a medical oncologist at Massachusetts General Hospital, said that despite advances in first-line treatment of advanced gastric and GEJ cancers, there is still an unmet medical need for these patients..

在Astellas宣布Vyloy获得批准时，哈佛医学院副教授兼马萨诸塞州总医院肿瘤内科医师Samuel Klempner博士表示，尽管晚期胃癌和GEJ癌症的一线治疗取得了进展，但这些患者的医疗需求仍未得到满足。。

“The approval of Vyloy, based on the pivotal Phase 3 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,” he said.

他说：“Vyloy的批准基于关键的第三阶段SPOTLE和GLOW试验，为CLDN18.2阳性肿瘤患者以及治疗决策一线的患者提供了一种新的生物标志物和新疗法。”。

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Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat.

卫生系统在门户网站上花费了数十亿美元，而对语音频道现代化的投资（这是医疗保健消费者的主要偏好）却处于次要地位。

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Vyloy was initially expected to receive an FDA decision early this year, but the agency rejected the drug’s application in January due to issues with the drug’s third-party manufacturer. The approval came ahead of the new Nov. 9 target date for a decision. Concurrent with the Vyloy approval, the FDA also approved a Roche companion diagnostic to identify patients eligible for treatment with the drug..

Vyloy最初预计会在今年年初收到FDA的决定，但由于该药物的第三方制造商存在问题，该机构于1月份拒绝了该药物的申请。批准日期早于11月9日新的决策目标日期。在Vyloy批准的同时，FDA还批准了罗氏伴侣诊断，以确定符合该药物治疗条件的患者。。

Astellas gained Vyloy from its 2016 acquisition of privately held Ganymede Pharmaceuticals for €422 million (about $462 million) up front. Another €860 million (about $930 million) is tied to the achievement of milestones. With the FDA approval of Vyloy, the U.S. is now the fifth market for the new Astellas drug.

Astellas于2016年以4.22亿欧元（约4.62亿美元）的价格收购了私人持有的Ganymede制药公司，从而获得了Vyloy。另外8.6亿欧元（约9.3亿美元）与里程碑的实现有关。随着FDA对Vyloy的批准，美国现在是新Astellas药物的第五个市场。

Japan was the first country to approve the drug in a regulatory decision handed out in March. Since then, Vyloy has landed affirmative regulatory decision in the United Kingdom, South Korea, and the European Union. The drug is still under review in other markets around the world..

日本是第一个在3月份发布的监管决定中批准该药物的国家。从那时起，维莱在英国、韩国和欧盟获得了肯定的监管决定。该药仍在世界其他市场进行审查。。

There are other companies pursuing CLDN18.2. The contender of Boston-based Elevation Oncology is EO-3021, an antibody drug conjugate (ADC) currently in early-stage clinical development as a monotherapy for advanced solid tumors, including gastric, GEJ, pancreatic, and esophageal cancers. Data from this study are expected in the first half of 2025.

还有其他公司追求CLDN18.2。波士顿高程肿瘤学的竞争者是EO-3021，这是一种抗体-药物偶联物（ADC），目前正在早期临床开发中，作为晚期实体瘤（包括胃癌，GEJ癌，胰腺癌和食道癌）的单一疗法。这项研究的数据预计将在2025年上半年发布。

A separate ongoing Phase 1 test is evaluating the Elevation drug in combination with Eli Lilly’s Cyramza and GSK’s Jemperli. Meanwhile, Merck KGaA could get a CLDN18.2 drug via a 2023 deal that granted it an option to license an ADC in development by Jiangsu Hengrui Pharmaceuticals..

一项单独的正在进行的第一阶段测试正在评估该药物与礼来公司的Cyramza和葛兰素史克公司的Jemperli的联合使用情况。与此同时，默克公司（Merck KGaA）可能通过2023年的协议获得CLDN18.2药物，该协议允许其选择许可江苏恒瑞制药正在开发的ADC。。

Photo: Kiyoshi Ota/Bloomberg, via Getty Images

照片：大田清吉/彭博社，通过盖蒂图片

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