Zolbetuximab

Last updated

Zolbetuximab
Monoclonal antibody
Type Whole antibody
Source Chimeric (mouse/human)
Target CLDN18.2
Clinical data
Trade names Vyloy
Other namesIMAB362, claudiximab, zolbetuximab-clzb
AHFS/Drugs.com Vyloy
License data
Routes of
administration 		Intravenous infusion
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
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Zolbetuximab, sold under the brand name Vyloy, is a monoclonal antibody used for the treatment of gastric cancer. [4] It is a claudin 18.2-directed cytolytic antibody against isoform 2 of Claudin-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]

Contents

Zolbetuximab was approved for medical use in Japan in March 2024, [9] in the European Union in September 2024, [5] and in the United States in October 2024. [10] [11] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [12]

Medical use

Zolbetuximab is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. [4] [5] [10]

Adverse effects

The most common adverse reactions include nausea, vomiting, decreased appetite, weight loss, neutropenia (low levels of neutrophils, a type of white blood cell that fights infections), fever, hypoalbuminemia (low levels of albumin, a blood protein), and peripheral edema (swelling, especially of the ankles and feet). [5]

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]

History

Zolbetuximab has been tested in two phase III clinical trials for gastric cancer, SPOTLIGHT and GLOW. [13] [14] A combined analysis of the two trials confirmed that zolbetuximab, when added to chemotherapy, improved progression-free survival and overall survival for patients with HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors were positive for claudin 18.2. [15]

Society and culture

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, 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. [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]

Names

Zolbetuximab is the international nonproprietary name. [18]

Zolbetuximab is sold under the brand name Vyloy. [4]

References

  1. ↑ https://www.tga.gov.au/resources/prescription-medicines-registrations/vyloy-astellas-pharma-australia-pty-ltd
  2. ↑ "Vyloy product information". Health Canada . 13 December 2024. Retrieved 27 December 2024.
  3. ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2025-02-26]". Health Canada . 26 February 2025. Retrieved 3 March 2025.
  4. 1 2 3 4 5 "Vyloy- zolbetuximab injection, powder, for suspension". DailyMed. 18 October 2024. Retrieved 31 October 2024.
  5. 1 2 3 4 5 6 7 8 "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.
  6. 1 2 "Vyloy PI". Union Register of medicinal products. 25 September 2024. Retrieved 27 September 2024.
  7. ↑ "Our mission - Ganymed Pharmaceuticals GmbH - Ganymed Pharmaceuticals GmbH". www.ganymed-pharmaceuticals.de. Archived from the original on 20 December 2013. Retrieved 20 December 2013.
  8. ↑ "Astellas Completes Acquisition of Ganymed Pharmaceuticals". Astellas Pharma. Archived from the original on 5 August 2020. Retrieved 20 January 2023.
  9. 1 2 "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.
  10. 1 2 3 "FDA Roundup: October 18, 2024". U.S. Food and Drug Administration (FDA) (Press release). 18 October 2024. Archived from the original on 21 October 2024. Retrieved 19 October 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  11. 1 2 "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). Archived from the original on 19 April 2024. Retrieved 28 October 2024.
  12. ↑ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  13. ↑ 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. PMID   37068504.
  14. ↑ Shah MA, Shitara K, Ajani JA, Bang YJ, Enzinger P, Ilson D, et al. (August 2023). "Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial". Nature Medicine. 29 (8): 2133–2141. doi:10.1038/s41591-023-02465-7. PMC   10427418 . PMID   37524953.
  15. ↑ Shitara K, Shah MA, Lordick F, Van Cutsem E, Ilson DH, Klempner SJ, et al. (September 2024). "Zolbetuximab in Gastric or Gastroesophageal Junction Adenocarcinoma". The New England Journal of Medicine. 391 (12): 1159–1162. doi:10.1056/NEJMc2409512. PMC   11937907 . PMID   39282934.
  16. ↑ "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.
  17. ↑ "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.
  18. ↑ 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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