Industry Insights: The first CAR-T approval in solid tumors and the FDA recalibrates

Abstract

June delivered a landmark for the CAR-T field alongside a distinct shift in US regulatory posture. CARsgen secured NMPA approval for satri-cel, the first CAR-T cell therapy approved for a solid tumor indication anywhere in the world, targeting Claudin18.2 in advanced gastric and gastroesophageal junction adenocarcinoma. In parallel, the US FDA signaled a more accommodating stance on accelerated approval, a shift coinciding with recent changes in agency leadership, as uniQure reversed course on AMT-130 for Huntington’s disease and REGENXBIO cleared a path to resubmit NAVSUNLI for MPS II (Hunter syndrome).