Zolbetuximab Explained
| Verifiedfields: | changed |
| Verifiedrevid: | 457124199 |
| Type: | mab |
| Mab Type: | mab |
| Source: | xi |
| Target: | CLDN18.2 |
| Tradename: | Vyloy |
| Atc Prefix: | None |
| Legal Status: | JP: Rx-only |
| Cas Number: | 1496553-00-4 |
| Chemspiderid: | none |
| Unii: | TF5MPQ8WGY |
| Kegg: | D11527 |
| Synonyms: | IMAB362; claudiximab |
Zolbetuximab, sold under the brand name Vyloy, is a monoclonal antibody against isoform 2 of Claudin-18 used for the treatment of gastric cancer.[1] It is under investigation for the treatment of gastrointestinal adenocarcinomas and pancreatic tumors. Zolbetuximab was developed by Ganymed Pharmaceuticals AG.[2] Astellas Pharmaceuticals acquired the rights to zolbetuximab in December 2016, when it acquired Ganymed Pharmaceuticals.[3]
History
Zolbetuximab was in phase III clinical trials for gastric cancer.[4] [5]
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.[6]
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.[7] [8] The applicant for this medicinal product is Astellas Pharma Europe B.V.
Names
Zolbetuximab is the international nonproprietary name.[9]
Notes and References
- Astellas' Vyloy (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer . Astellas Pharma . PR Newswire . 26 March 2024 . 19 April 2024 . 19 April 2024 . https://web.archive.org/web/20240419022120/https://www.prnewswire.com/news-releases/astellas-vyloy-zolbetuximab-approved-in-japan-for-treatment-of-gastric-cancer-302098760.html . live .
- Web site: Our mission - Ganymed Pharmaceuticals GmbH - Ganymed Pharmaceuticals GmbH. www.ganymed-pharmaceuticals.de. 20 December 2013. 20 December 2013. https://web.archive.org/web/20131220232719/http://www.ganymed-pharmaceuticals.de/pipeline/imab362.html. live.
- Web site: Astellas Completes Acquisition of Ganymed Pharmaceuticals . Astellas Pharma Inc. . 20 January 2023 . 5 August 2020 . https://web.archive.org/web/20200805225957/https://www.astellas.com/en/news/7846 . live .
- Shitara K, Lordick F, Bang YJ, Enzinger PC, Ilson DH, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J . 19 January 2023 . Zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) with claudin-18.2+ (CLDN18.2+) / HER2− locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Primary results from phase 3 SPOTLIGHT study . . 41 . suppl 4 . abstr LBA292 . 10.1200/JCO.2023.41.3_suppl.LBA292 . 31 January 2024 . 7 February 2023 . 15 January 2023 . https://web.archive.org/web/20230115134537/https://meetings.asco.org/abstracts-presentations/217453 . live .
- Web site: Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium . 19 January 2023 . 19 January 2023 . https://web.archive.org/web/20230119181422/https://newsroom.astellas.us/2023-01-19-Astellas-to-Present-Positive-Findings-from-Phase-3-SPOTLIGHT-Trial-of-Zolbetuximab-during-2023-ASCO-GI-Cancers-Symposium . live .
- Web site: Japan's MHLW Approves Zolbetuximab in CLDN18.2-Positive Gastric Cancer . 26 March 2024 . onclive.com . 18 April 2024 . 18 April 2024 . https://web.archive.org/web/20240418013130/https://www.onclive.com/view/japan-s-mhlw-approves-zolbetuximab-in-cldn18-2-positive-gastric-cancer . live .
- Web site: Vyloy EPAR . European Medicines Agency . 25 July 2024 . 25 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024 . European Medicines Agency . 25 July 2024 . 29 July 2024.
- ((World Health Organization)) . 2018 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79 . WHO Drug Information . 32 . 1 . 10665/330941 . free . World Health Organization .
