Zolbetuximab, sold under the brand name Vyloy, is a monoclonal antibody used for the treatment of gastric cancer.[1][4] It is a claudin 18.2-directed cytolytic antibody against isoform 2 of Claudin-18.[1] Zolbetuximab was developed by Ganymed Pharmaceuticals.[5] Astellas Pharma acquired the rights to zolbetuximab in December 2016, when it acquired Ganymed Pharmaceuticals.[6]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric (mouse/human) |
| Target | CLDN18.2 |
| Clinical data | |
| Trade names | Vyloy |
| Other names | IMAB362, claudiximab, zolbetuximab-clzb |
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| Routes of administration | Intravenous infusion |
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The most common adverse reactions include nausea, vomiting, decreased appetite, neutropenia (low levels of neutrophils, a type of white blood cell that fights infections), decreased neutrophil counts, weight loss, fever, hypoalbuminemia (low levels of albumin, a blood protein), and peripheral edema (swelling, especially of the ankles and feet).[2]
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.[1][2][7]
Adverse effects
The most common adverse reactions include nausea, vomiting, decreased appetite, neutropenia (low levels of neutrophils, a type of white blood cell that fights infections), decreased neutrophil counts, weight loss, fever, hypoalbuminemia (low levels of albumin, a blood protein), and peripheral edema (swelling, especially of the ankles and feet).[2]
Other side effects include hypertension (high blood pressure), dyspepsia (indigestion), chills, salivary hypersecretion (excess production of saliva), infusion-related reactions and hypersensitivity (allergic reactions).[2]
History
Zolbetuximab was in phase III clinical trials as of November 2021[update] for gastric cancer.[8][9]
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.[4][10]
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.[2][11] The applicant for this medicinal product is Astellas Pharma Europe B.V.[2] Vyloy was authorized for medical use in the European Union in September 2024.[2]
Zolbetuximab-clzb was approved for medical use in the United States in October 2024.[2][7]
Names
Zolbetuximab is the international nonproprietary name.[12]
References
External links
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