Gastric Adenocarcinoma

The FDA announced several regulatory actions.

First-line treatment with zolbetuximab added to chemotherapy significantly extended OS and PFS among adults with certain forms of claudin-18.2-positive/HER2-negative gastric adenocarcinoma, results of the phase 3 SPOTLIGHT trial showed.

Stomach cancer — also known as gastric cancer — is uncommon in the United States, making up only 1.4% of all new cancer cases in 2021, and the number of people diagnosed with it each year is declining.

The FDA granted orphan drug designation to CYNK-101, an investigational natural killer cell-based therapy for treatment of advanced HER2/neu-positive gastric or gastroesophageal junction adenocarcinoma.

The FDA granted regenerative medicine advanced therapy designation to CT041, a chimeric antigen receptor T-cell therapy for adults with relapsed or refractory gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

The FDA cleared an investigational new drug application for CYNK-101, a natural killer cell therapy for the treatment of patients with advanced HER2/neu-positive gastric or gastroesophageal junction adenocarcinoma.

The addition of sintilimab to first-line chemotherapy extended OS among patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, according to topline results of a randomized phase 3 trial.

The FDA granted accelerated approval to a pembrolizumab-based combination for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.