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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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]
Names[edit]
Zolbetuximab is the international nonproprietary name.[9]
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) CS1 maint: overridden setting (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.
- ^ 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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