Paul E. Oberstein, MD, discusses data for an autogene cevumeran–based regimen in pancreatic ductal adenocarcinoma.
News|Articles|May 3, 2026
April’s GI Monthly Rewind: Key Regulatory Updates You May Have Missed
Author(s)Courtney Flaherty
Fact checked by: Kyle Doherty
A one-stop-shop for regulatory updates across GI malignancies from the past month.
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April’s gastrointestinal (GI) regulatory landscape was characterized by a surge in specialized FDA designations aimed at accelerating the development of precision tools for difficult-to-treat malignancies. Of note, the FDA granted priority review to zanidatamab-hrii (Ziihera)–based regimens for HER2-positive gastroesophageal adenocarcinoma (GEA) and accepted a supplemental biologics license application (sBLA) for zenocutuzumab-zbco (Bizengri) in NRG1 fusion–positive cholangiocarcinoma.1,3
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