May’s GI Monthly Rewind: A Landmark Approval in CCA, Expanded Access for Daraxonrasib, and More Key Pipeline Updates

The global gastrointestinal regulatory landscape doesn’t slow down, and May was no exception. The month’s headline was the FDA’s landmark approval of zenocutuzumab-zbco (Bizengri) for NRG1 fusion–positive cholangiocarcinoma, the first targeted therapy cleared for this rare biliary malignancy.¹ In pancreatic ductal adenocarcinoma (PDAC), May also brought a pivotal moment for the pan-RAS inhibitor daraxonrasib (RMC-6236), with the FDA issuing a “safe to proceed” letter for an expanded access protocol, enabling patients outside clinical trials to access what many are calling the most impactful drug in pancreatic cancer in more than a decade.²