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Zolbetuximab is the first drug against Claudin 18.2, a protein exposed on stomach cancer cells. Added to chemotherapy it extends survival by two to three months; nausea is the price.
Chimeric IgG1 binding CLDN18.2, killing via ADCC and CDC. SPOTLIGHT and GLOW positive; FDA approval 18 October 2024 with a companion IHC assay (VENTANA CLDN18). Eligible patients are CLDN18.2 ≥75% moderate-to-strong membranous staining, HER2-negative. Nausea and vomiting occur in most patients in cycle 1 and need aggressive antiemetic prophylaxis and infusion-rate adjustment.
Backbone ribbon from PDB 9V32. RCSB PDB 9V32. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Binds CLDN18.2 exposed on malignant gastric cells; Fc-mediated ADCC and complement-dependent cytotoxicity. Connects to Claudin 18.2.
1.Normal stomach cells hide Claudin 18.2 inside tight junctions; cancer cells expose it on their surface
Source: www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf. Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA-approved 2024 for CLDN18.2-positive gastric/GEJ cancer.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. CLDN18.2 IHC result required.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA1046. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
World-first approval
SPOTLIGHT/GLOW; companion diagnostic VENTANA CLDN18 (43-14A)
| Region | Year | Indication |
|---|---|---|
| Japan | 2024 | CLDN18.2+ HER2- gastric cancer (first approval, March 2024) |
| US | 2024 | First-line CLDN18.2+ (≥75%), HER2- locally advanced/metastatic gastric or GEJ adenocarcinoma with fluoropyrimidine/platinum chemotherapy |
| EU | 2024 | 1L CLDN18.2+ HER2- gastric/GEJ; 19 Sep 2024 |
| Adverse event |
|---|
| Nausea Most patients; worst in cycle 1 |
| Vomiting Most patients; infusion-related |
| Decreased appetite |
| Hypersensitivity/infusion reactions |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Zolbetuximab" OR ABSTRACT:"Zolbetuximab" OR TITLE:"Vyloy" OR ABSTRACT:"Vyloy" OR TITLE:"IMAB362" OR ABSTRACT:"IMAB362") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Zolbetuximab, not a curated reading list.
Shares Yoon-Koo Kang, Kohei Shitara, ADCC (antibody-dependent cellular cytotoxicity), Claudin 18.2-positive gastric cancer.
Shares CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression, Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2, Claudin 18.2-positive gastric cancer, Claudin 18.2.
Shares GLOW: zolbetuximab plus CAPOX in claudin 18.2-positive, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, Claudin 18.2-positive gastric cancer, Gastric & gastro-oesophageal junction cancer.
Shares CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression, Claudin 18.2, Oesophageal cancer, Gastric & gastro-oesophageal junction cancer.
Shares Min-Hee Ryu, PD-L1-high gastric cancer, Monoclonal antibodies, Gastric & gastro-oesophageal junction cancer.
Shares Claudin 18.2-positive gastric cancer, Claudin 18.2, Astellas, Gastric & gastro-oesophageal junction cancer.
Shares Kohei Shitara, PD-L1-high gastric cancer, Oesophageal and junctional adenocarcinoma, Oesophageal cancer.
Shares Yoon-Koo Kang, PD-L1-high gastric cancer, Gastric & gastro-oesophageal junction cancer.