Check out this October recap of OncLive’s coverage of the top news and expert insights in gastrointestinal cancers.
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.
Advertisement
Advertisement
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
Related to this article
The top 5 OncLive TV videos of the week cover insights in NSCLC, gynecologic cancers, CRC, multiple myeloma, and NMIBC.
Experts break down key gastrointestinal cancer data and trends from the 2026 ESMO Congress.
Lirafugratinib was added as a category 2A subsequent-line option for cholangiocarcinoma with an FGFR2 fusion or rearrangement and disease progression.
Sarah Goldberg, MD, MPH, details how clinicians can choose among frontline regimens, act on resistance mechanisms, and incorporate ADCs and newer agents across the spectrum of EGFR-mutated NSCLC.
The FDA approved pimicotinib for tenosynovial giant cell tumor, accepted a gedatolisib filing in advanced breast cancer, and more.
Serial amino acid PET flagged responses earlier than MRI in IDH-mutant glioma treated with vorasidenib, interim data show.
Longer mirdametinib treatment increased confirmed and deep responses as treatment-related adverse effects declined in neurofibromatosis type 1 tumors.
Advertisement
Advertisement