Zolbetuximab
Monoclonal antibody
From Wikipedia, the free encyclopedia
Zolbetuximab, sold under the brand name Vyloy, is a monoclonal antibody used for the treatment of gastric cancer.[4] It is a claudin 18.2-directed cytolytic antibody against isoform 2 of Claudin-18.[4] Zolbetuximab was developed by Ganymed Pharmaceuticals.[7] Astellas Pharma acquired the rights to zolbetuximab in December 2016, when it acquired Ganymed Pharmaceuticals.[8]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric (mouse/human) |
| Target | CLDN18.2 |
| Clinical data | |
| Trade names | Vyloy |
| Other names | IMAB362, claudiximab, zolbetuximab-clzb |
| AHFS/Drugs.com | Vyloy |
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| Routes of administration | Intravenous infusion |
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| Legal status | |
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Zolbetuximab was approved for medical use in Japan in March 2024,[9] in the European Union in September 2024,[5] and in the United States in October 2024.[10][11] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[12]
Medical use
Zolbetuximab is indicated 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 adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.[4][5][10]
Adverse effects
The most common adverse reactions include nausea, vomiting, decreased appetite, weight loss, neutropenia (low levels of neutrophils, a type of white blood cell that fights infections), fever, hypoalbuminemia (low levels of albumin, a blood protein), and peripheral edema (swelling, especially of the ankles and feet).[5]
Other side effects include hypertension (high blood pressure), dyspepsia (indigestion), chills, salivary hypersecretion (excess production of saliva), infusion-related reactions and hypersensitivity (allergic reactions).[5]
History
Zolbetuximab has been tested in two phase III clinical trials for gastric cancer, SPOTLIGHT and GLOW.[13][14] A combined analysis of the two trials confirmed that zolbetuximab, when added to chemotherapy, improved progression-free survival and overall survival for patients with HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors were positive for claudin 18.2.[15]
Society and culture
Legal status
In Japan, zolbetuximab is approved for the treatment of people with CLDN18.2-positive, unresectable, advanced, or recurrent gastric cancer.[9][16]
In July 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vyloy, intended for the treatment of gastric or gastro-esophageal junction adenocarcinoma.[5][17] The applicant for this medicinal product is Astellas Pharma Europe B.V.[5] Vyloy was authorized for medical use in the European Union in September 2024.[5][6]
Zolbetuximab was approved for medical use in the United States in October 2024.[10][11]
Names
Zolbetuximab is the international nonproprietary name.[18]
Zolbetuximab is sold under the brand name Vyloy.[4]
