Zolbetuximab, sold under the brand name Vyloy, is a monoclonal antibody used for the treatment of gastric cancer.[2] It is a claudin 18.2-directed cytolytic antibody against isoform 2 of Claudin-18.[2] Zolbetuximab was developed by Ganymed Pharmaceuticals.[5] Astellas Pharma acquired the rights to zolbetuximab in December 2016, when it acquired Ganymed Pharmaceuticals.[6]
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).[3]
Other side effects include hypertension (high blood pressure), dyspepsia (indigestion), chills, salivary hypersecretion (excess production of saliva), infusion-related reactions and hypersensitivity (allergic reactions).[3]
In Japan, zolbetuximab is approved for the treatment of people with CLDN18.2-positive, unresectable, advanced, or recurrent gastric cancer.[7][13]
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.[3][14] The applicant for this medicinal product is Astellas Pharma Europe B.V.[3] Vyloy was authorized for medical use in the European Union in September 2024.[3]
Zolbetuximab was approved for medical use in the United States in October 2024.[8][9]
^ abcdefghi"Vyloy EPAR". European Medicines Agency. 25 July 2024. Retrieved 25 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^"Vyloy PI". Union Register of medicinal products. 25 September 2024. Retrieved 27 September 2024.
^World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
External links
Clinical trial number NCT03504397 for "A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight)" at ClinicalTrials.gov
Clinical trial number NCT03653507 for "A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW)" at ClinicalTrials.gov
