Stomach (Gastric) Cancer

Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.

Latest Discoveries

FDA approves zolbetuximab for CLDN18.2-positive gastric and gastroesophageal junction cancer

Evidence stage: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Stomach (Gastric) Cancer
Published
August 13, 2026

In two separate, randomized, double-blind, phase 3 trials (SPOTLIGHT and GLOW), adding zolbetuximab to first-line chemotherapy significantly extended both progression-free survival and overall survival, compared with chemotherapy alone, in patients…

Primary source cited

Last reviewed

Major Advances

FDA approves zolbetuximab for CLDN18.2-positive gastric and gastroesophageal junction cancer

Evidence stage: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Stomach (Gastric) Cancer
Published
August 13, 2026

In two separate, randomized, double-blind, phase 3 trials (SPOTLIGHT and GLOW), adding zolbetuximab to first-line chemotherapy significantly extended both progression-free survival and overall survival, compared with chemotherapy alone, in patients…

Primary source cited

Last reviewed

FDA Approvals

Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.

FDA approves zolbetuximab for CLDN18.2-positive gastric and gastroesophageal junction cancer

Regulatory status: FDA ApprovedEvidence stage: High-Certainty Evidence
Cancer type
Stomach (Gastric) Cancer
Population
Adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive, previously untreated, randomized to zolbetuximab plus chemotherapy or placebo plus chemotherapy (SPOTLIGHT trial population; a second, similarly-designed trial, GLOW, also supported this approval).
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
First-line treatment, in combination with fluoropyrimidine- and platinum-containing chemotherapy, of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
Biomarker requirement
CLDN18.2-positive by an FDA-approved companion diagnostic; HER2-negative
Decision date
2024-10-18

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

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Related resources

Trusted resources: official cancer information

CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.