Zolbetuximab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric |
| Target | CLDN18.2 |
| Clinical data | |
| Trade names | Vyloy |
| Other names | IMAB362; claudiximab |
| ATC code |
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| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number | |
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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
[edit]Zolbetuximab was in phase III clinical trials as of November 2021[update] for gastric cancer.[4][5][6][7]
Society and culture
[edit]Legal status
[edit]In Japan, zolbetuximab is approved for the treatment of people with CLDN18.2-positive, unresectable, advanced, or recurrent gastric cancer.[1][8]
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 authorisation for the medicinal product Vyloy1, intended for the treatment of gastric or gastro-oesophageal junction (GEJ) adenocarcinoma.[9][10] The applicant for this medicinal product is Astellas Pharma Europe B.V.[9]
Names
[edit]Zolbetuximab is the international nonproprietary name.[11]
References
[edit]- ^ a b "Astellas' Vyloy (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer" (Press release). Astellas Pharma. 26 March 2024. Archived from the original on 19 April 2024. Retrieved 19 April 2024 – via PR Newswire.
- ^ "Our mission - Ganymed Pharmaceuticals GmbH - Ganymed Pharmaceuticals GmbH". www.ganymed-pharmaceuticals.de. Archived from the original on 20 December 2013. Retrieved 20 December 2013.
- ^ "Astellas Completes Acquisition of Ganymed Pharmaceuticals". Astellas Pharma Inc. Archived from the original on 5 August 2020. Retrieved 20 January 2023.
- ^ 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
- ^ 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
- ^ Shitara K, Lordick F, Bang YJ, Enzinger PC, Ilson DH, Shah MA, et al. (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". J Clin Oncol. 41 (suppl 4): abstr LBA292. doi:10.1200/JCO.2023.41.3_suppl.LBA292 (inactive 31 January 2024). Archived from the original on 15 January 2023. Retrieved 7 February 2023.
{{cite journal}}: CS1 maint: DOI inactive as of January 2024 (link) - ^ "Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium". Archived from the original on 19 January 2023. Retrieved 19 January 2023.
- ^ "Japan's MHLW Approves Zolbetuximab in CLDN18.2-Positive Gastric Cancer". onclive.com. 26 March 2024. Archived from the original on 18 April 2024. Retrieved 18 April 2024.
- ^ a b "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.
- ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024". European Medicines Agency (Press release). 25 July 2024. Retrieved 29 July 2024.
- ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
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