zolbetuximab (Pending FDA Approval)

Action and Spectrum

Actions and Spectrum: 

Actions:  

Zolbetuximab (IMAB362) is a Claudin-18.2 monoclonal antibody. Through immunological effector pathways, zolbetuximab causes selective death of Claudin-18.2-positive cells. Zolbetuximab is being studied for gastrointestinal adenocarcinomas and pancreatic malignancies. 

Spectrum: 

Zolbetuximab is a monoclonal antibody that targets the protein claudin 18.2 (CLDN18.2). Certain malignancies, such as gastric (stomach) cancer and gastroesophageal junction (GEJ) cancer, have high levels of this protein. Because zolbetuximab is specific for CLDN18.2, it can bind to cancer cells that contain this protein. 

Drug Interaction

Adverse Reaction

N/A 

Black Box Warning

Black Box Warning: 

 N/A 

Contraindication / Caution

N/A 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

Clinical trials are evaluating zolbetuximab for the treatment of gastroesophageal junction adenocarcinoma (GEJC) and HER2-negative, CLDN18.2-positive, locally advanced gastric cancer (GC) or any history of metastasis if untreated. Cancers known as GC and GEJC originate in the stomach’s inner lining or at the junction of the esophagus and stomach. 

Pharmacodynamics: N/A 

Pharmacokinetics: N/A 

Adminstartion

N/A  

Patient Information Leaflet

Patient information leaflet 

Generic Name: zolbetuximab 

Pronounced: zol-beh-tux-i-mab 

Why do we use zolbetuximab? 

Zolbetuximab is a monoclonal antibody that is used to treat some forms of cancer, particularly gastrointestinal cancers. It targets a specific protein that is frequently overexpressed in some malignancies.