Zolbetuximab
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.
1.Normal stomach cells hide Claudin 18.2 inside tight junctions; cancer cells expose it on their surface
- Route
- Intravenous
- Schedule
- 800 mg/m² loading, then 600 mg/m² every 3 weeks or 400 mg/m² every 2 weeks with chemotherapy
- Dose modifications
- Slow or interrupt infusion for nausea/vomiting; premedicate with antiemetics
- Monitoring
- Nausea/vomiting in cycle 1; hypersensitivity
Source: www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Astellas Pharma Support Solutions
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Notes
- MHRA-licensed 2024-25 for CLDN18.2-positive gastric cancer; NICE appraisal in progress.
Sources: NICE search: zolbetuximab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- Mar 2024ApprovalJapan
World-first approval
- 18 Oct 2024ApprovalUS
SPOTLIGHT/GLOW; companion diagnostic VENTANA CLDN18 (43-14A)
Approvals
| 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 |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.