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Zolbetuximab, sold under the brand name Vyloy, is a monoclonal antibody used for the treatment of gastric cancer. It is a claudin 18.2-directed cytolytic antibody against isoform 2 of Claudin-18. Zolbetuximab was developed by Ganymed Pharmaceuticals. Astellas Pharma acquired the rights to zolbetuximab in December 2016, when it acquired Ganymed Pharmaceuticals.

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).

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.

Adverse effects

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).

Other side effects include hypertension (high blood pressure), dyspepsia (indigestion), chills, salivary hypersecretion (excess production of saliva), infusion-related reactions and hypersensitivity (allergic reactions).

History

Zolbetuximab was in phase III clinical trials as of November 2021 for gastric cancer.

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.

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. The applicant for this medicinal product is Astellas Pharma Europe B.V. Vyloy was authorized for medical use in the European Union in September 2024.

Zolbetuximab-clzb was approved for medical use to treat gastric or gastroesophageal junction adenocarcinoma in the United States in October 2024.

Names

Zolbetuximab is the international nonproprietary name.

References

1. ^ "Vyloy- zolbetuximab injection, powder, for suspension". DailyMed. 18 October 2024. Retrieved 31 October 2024.
2. ^ "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.
3. "Vyloy PI". Union Register of medicinal products. 25 September 2024. Retrieved 27 September 2024.
4. ^ "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.
5. "Our mission - Ganymed Pharmaceuticals GmbH - Ganymed Pharmaceuticals GmbH". www.ganymed-pharmaceuticals.de. Archived from the original on 20 December 2013. Retrieved 20 December 2013.
6. "Astellas Completes Acquisition of Ganymed Pharmaceuticals". Astellas Pharma. Archived from the original on 5 August 2020. Retrieved 20 January 2023.
7. ^ "FDA Roundup: October 18, 2024". U.S. Food and Drug Administration (FDA) (Press release). 18 October 2024. Retrieved 19 October 2024. This article incorporates text from this source, which is in the public domain.
8. 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 1 November 2024). Archived from the original on 15 January 2023. Retrieved 7 February 2023.{{cite journal}}: CS1 maint: DOI inactive as of November 2024 (link)
9. "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.
10. "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.
11. "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.
12. "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). Retrieved 28 October 2024.
13. World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.

External links

• 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
• 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

• Medicine

• Drugs not assigned an ATC code
• Antineoplastic drugs
• Monoclonal antibodies
• Orphan drugs