March’s GI Monthly Rewind: Diagnostic Developments and FDA Alignments You Need to Know

March’s top regulatory updates in gastrointestinal (GI) malignancies were primarily pipeline related, with endorsement of a pivotal phase 3 trial design for an oncolytic virus in pancreatic cancer and a potential accelerated approval pathway for a novel Claudin 18.2–directed therapy in gastric cancer. Additional regulatory milestones were reached in the US and abroad, with the FDA approval of a companion diagnostic for esophageal and gastroesophageal junction (GEJ) carcinomas, FDA orphan drug designation for RCT1213 in hepatocellular carcinoma (HCC), and submission of a marketing application for ripretinib in Japan for gastrointestinal stromal tumors (GISTs).