Gastric Adenocarcinoma
Gastric Adenocarcinoma
Gastric Adenocarcinoma
FDA grants priority review to therapy for relapsed leukemia, lymphoma
The FDA announced several regulatory actions.
Zolbetuximab benefits subset of patients with gastric, gastroesophageal junction cancer
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.
FDA grants orphan drug designation to natural killer cell therapy for GI cancers
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.
FDA grants RMAT designation to CAR T-cell therapy for advanced gastric cancers
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.
FDA clears application for natural killer cell therapy to treat gastrointestinal cancers
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.
Sintilimab regimen extends OS in gastric, 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.
FDA approves first-line Keytruda-based regimen for advanced HER2-positive gastric cancer
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.
FDA grants orphan drug designation to CAR T-cell therapy for advanced gastric cancers
The FDA granted orphan drug designation to CT041 for the treatment of adults with relapsed or refractory gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, according to the agent’s manufacturer.