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…
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…
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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.
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).
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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
SPOTLIGHT trial primary results: zolbetuximab plus mFOLFOX6 in CLDN18.2-positive gastric/GEJ adenocarcinoma (The Lancet). DOI 10.1016/S0140-6736(23)00620-7, PMID 37068504.
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