Approval Alert | Zolbetuximab/Chemotherapy in Advanced CLDN18.2+ Gastric/GEJ Adenocarcinoma

John Marshall, MD, discussed zolbetuximab, which the FDA recently approved for patients with CLDN18.2–positive locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma.

Additional genetic testing measures and targeted therapies may improve outcomes for patients with diverse molecular subgroups of gastric cancers.

Data from the SPOTLIGHT and GLOW trials reveal that zolbetuximab increased survival in patients with CLDN18.2-positive gastric or GEJ adenocarcinoma.

The incorporation of zolbetuximab in addition to chemotherapy has shown benefit in patients with Claudin 18.2–positive gastric cancers in clinical trials.

Data from the phase 3 SPOTLIGHT trial and the phase 3 GLOW trial supported the approval of zolbetuximab plus chemotherapy in this indication.