Zolbetuximab, sold under the brand nameVyloy, is amonoclonal antibody used for the treatment ofgastric cancer.[4] It is a claudin 18.2-directed cytolytic antibody againstisoform 2 ofClaudin-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]
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]
Zolbetuximab has been tested in two phase III clinical trials forgastric cancer, SPOTLIGHT and GLOW.[13][14] A combined analysis of the two trials confirmed that zolbetuximab, when added to chemotherapy, improvedprogression-free survival andoverall survival for patients withHER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors were positive for claudin 18.2.[15]
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, theCommittee for Medicinal Products for Human Use of theEuropean 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]
^abcdefgh"Vyloy EPAR".European Medicines Agency. 25 July 2024. Retrieved25 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ab"Vyloy PI".Union Register of medicinal products. 25 September 2024. Retrieved27 September 2024.
^Shitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, et al. (May 2023). "Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial".Lancet.401 (10389):1655–1668.doi:10.1016/S0140-6736(23)00620-7.PMID37068504.
^World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79".WHO Drug Information.32 (1).hdl:10665/330941.
Clinical trial numberNCT03504397 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)" atClinicalTrials.gov
Clinical trial numberNCT03653507 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)" atClinicalTrials.gov
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