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Revision as of 10:26, 24 October 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Script assisted update of identifiers for the Chem/Drugbox validation project (updated: 'CAS_number').  Latest revision as of 16:47, 2 November 2024 edit Citation bot (talk | contribs)Bots5,391,939 edits Altered doi-broken-date. | Use this bot. Report bugs. | #UCB_CommandLine 
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{{Short description|Monoclonal antibody}}
{{Drugbox
{{Use dmy dates|date=May 2024}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Infobox drug
| Verifiedfields = changed | Verifiedfields = changed
| verifiedrevid = 449166871 | verifiedrevid = 457124199
| type = mab | type = mab
| image = | image =
| alt = | alt =

<!-- Monoclonal antibody data -->
| mab_type = mab | mab_type = mab
| source = zu/o | source = xi/o
| target = ] | target = ].2

| tradename =
<!-- Clinical data -->
| Drugs.com =
| pronounce =
| tradename = Vyloy
| Drugs.com = {{drugs.com|parent|Vyloy}}
| MedlinePlus = | MedlinePlus =
| DailyMedID = Zolbetuximab
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category= | pregnancy_category=
| routes_of_administration = ]
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> | class =
| ATC_prefix = None <!-- Scheduled to be L01FX31 in 2025 -->
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM -->
| ATC_suffix =
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_status = | ATC_supplemental =
| biosimilars =
| routes_of_administration =

<!-- Legal status -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU_comment =
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Vyloy FDA label" />
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Vyloy EPAR" /><ref>{{cite web | title=Vyloy PI | website=Union Register of medicinal products | date=25 September 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1856.htm | access-date=27 September 2024}}</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = JP: Rx-only

<!-- Pharmacokinetic data -->
| bioavailability = | bioavailability =
| protein_bound = | protein_bound =
| metabolism = | metabolism =
| metabolites =
| onset =
| elimination_half-life = | elimination_half-life =
| duration_of_action =
| excretion = | excretion =

| CAS_number_Ref = {{cascite|correct|??}}
<!-- Identifiers -->
| CAS_number = <!-- blanked - oldvalue: 912628-39-8 -->
| ATC_prefix = none | CAS_number = 1496553-00-4
| ATC_suffix = | CAS_supplemental =
| PubChem = | PubChem =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = | DrugBank =
| ChemSpiderID = none
| C=6334 | H=9792 | N=1700 | O=2000 | S=42
| UNII = TF5MPQ8WGY
| molecular_weight = 143.1 kDa
| KEGG = D11527
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = NA | ChEBI =
| ChEMBL =
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = IMAB362, claudiximab, zolbetuximab-clzb
}} }}


'''Zolbetuximab''', sold under the brand name '''Vyloy''', is a ] used for the treatment of ].<ref name="Vyloy FDA label">{{cite web | title=Vyloy- zolbetuximab injection, powder, for suspension | website=DailyMed | date=18 October 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e7695a21-abb6-47ac-93f8-0ece5a9c4409 | access-date=31 October 2024}}</ref><ref name="Astellas PR">{{cite press release | title=Astellas' Vyloy (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer | publisher=Astellas Pharma | via=PR Newswire | date=26 March 2024 | url=https://www.prnewswire.com/news-releases/astellas-vyloy-zolbetuximab-approved-in-japan-for-treatment-of-gastric-cancer-302098760.html | access-date=19 April 2024 | archive-date=19 April 2024 | archive-url=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 | url-status=live }}</ref> It is a claudin 18.2-directed cytolytic antibody against ] 2 of ].<ref name="Vyloy FDA label" /> Zolbetuximab was developed by Ganymed Pharmaceuticals.<ref>{{cite web|url=http://www.ganymed-pharmaceuticals.de/pipeline/imab362.html|title=Our mission - Ganymed Pharmaceuticals GmbH - Ganymed Pharmaceuticals GmbH|website=www.ganymed-pharmaceuticals.de|access-date=20 December 2013|archive-date=20 December 2013|archive-url=https://web.archive.org/web/20131220232719/http://www.ganymed-pharmaceuticals.de/pipeline/imab362.html|url-status=live}}</ref> Astellas Pharma acquired the rights to zolbetuximab in December 2016, when it acquired Ganymed Pharmaceuticals.<ref>{{cite web | url=https://www.astellas.com/en/news/7846 | title=Astellas Completes Acquisition of Ganymed Pharmaceuticals | work=Astellas Pharma | access-date=20 January 2023 | archive-date=5 August 2020 | archive-url=https://web.archive.org/web/20200805225957/https://www.astellas.com/en/news/7846 | url-status=live }}</ref>
'''Enavatuzumab''' is a humanized monoclonal antibody used in the treatment of solid tumors.


The most common adverse reactions include ], ], ], ] (low levels of neutrophils, a type of white blood cell that fights infections), decreased neutrophil counts, ], ], ] (low levels of albumin, a blood protein), and ] (swelling, especially of the ankles and feet).<ref name="Vyloy EPAR" />
Enavatuzumab was developed by Facet Biotech Corp.<ref>{{cite web|title=Statement On A Nonproprietary Name Adopted By The USAN Council: Enavatuzumab|publisher=]|url=http://www.ama-assn.org/resources/doc/usan/enavatuzumab.pdf}}</ref>


== References == == Medical use ==
Zolbetuximab is ] in combination with ]- and ] for the ] of adults with locally advanced unresectable or metastatic ] (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.<ref name="Vyloy FDA label" /><ref name="Vyloy EPAR" /><ref name="FDA PR 20241018" />


== Adverse effects ==
<references/>
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).<ref name="Vyloy EPAR" />

Other side effects include hypertension (high blood pressure), dyspepsia (indigestion), chills, salivary hypersecretion (excess production of saliva), infusion-related reactions and hypersensitivity (allergic reactions).<ref name="Vyloy EPAR" />

== History ==
Zolbetuximab was in phase III clinical trials {{as of|2021|11|lc=on}} for ].<ref name=Shitara2023-ASCO>{{cite journal |vauthors=Shitara K, Lordick F, Bang YJ, Enzinger PC, Ilson DH, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J |date=19 January 2023 |title=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 |url=https://meetings.asco.org/abstracts-presentations/217453 |journal=] |volume=41 |issue=suppl 4 |pages=abstr LBA292 |doi=10.1200/JCO.2023.41.3_suppl.LBA292 |doi-broken-date=1 November 2024 |access-date=7 February 2023 |archive-date=15 January 2023 |archive-url=https://web.archive.org/web/20230115134537/https://meetings.asco.org/abstracts-presentations/217453 |url-status=live }}</ref><ref>{{cite web | url=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 | title=Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium | access-date=19 January 2023 | archive-date=19 January 2023 | archive-url=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 | url-status=live }}</ref>

== 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.<ref name="Astellas PR" /><ref>{{cite web | url = https://www.onclive.com/view/japan-s-mhlw-approves-zolbetuximab-in-cldn18-2-positive-gastric-cancer | title = Japan's MHLW Approves Zolbetuximab in CLDN18.2-Positive Gastric Cancer | date = 26 March 2024 | website = onclive.com | access-date = 18 April 2024 | archive-date = 18 April 2024 | archive-url = https://web.archive.org/web/20240418013130/https://www.onclive.com/view/japan-s-mhlw-approves-zolbetuximab-in-cldn18-2-positive-gastric-cancer | url-status = live }}</ref>

In July 2024, the ] of the ] 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.<ref name="Vyloy EPAR">{{cite web | title=Vyloy EPAR | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vyloy | access-date=25 July 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite press release | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024 | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2024 | access-date=29 July 2024}}</ref> The applicant for this medicinal product is Astellas Pharma Europe B.V.<ref name="Vyloy EPAR" /> Vyloy was authorized for medical use in the European Union in September 2024.<ref name="Vyloy EPAR" />

Zolbetuximab-clzb was approved for medical use to treat gastric or gastroesophageal junction adenocarcinoma in the United States in October 2024.<ref name="Vyloy EPAR" /><ref name="FDA PR 20241018">{{cite press release | title=FDA Roundup: October 18, 2024 | website=U.S. ] (FDA) | date=18 October 2024 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-october-18-2024 | access-date=19 October 2024}} {{PD-notice}}</ref><ref>{{Cite web |access-date=28 October 2024 |title=Novel Drug Approvals for 2024 |url=https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 |website=U.S. ] (FDA) }}</ref>

=== Names ===
Zolbetuximab is the ].<ref>{{cite journal | vauthors = ((World Health Organization)) | year = 2018 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79 | journal = WHO Drug Information | volume = 32 | issue = 1 | hdl = 10665/330941 | hdl-access = free | author-link = World Health Organization }}</ref>

== References ==
{{reflist}}


== External links ==
{{monoclonals for tumors}}
* {{ClinicalTrialsGov|NCT03504397|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)}}
* {{ClinicalTrialsGov|NCT03653507|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)}}


{{Targeted cancer therapeutic agents}}
{{Monoclonals for tumors}}
{{Portal bar | Medicine}}
{{Authority control}}


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