Read a refresh of GI cancer FDA news from July 2026, including an NDA acceptance for a RAS(ON) inhibitor in pancreatic cancer.
News|Articles|February 28, 2026
GI Monthly Rewind: Key Regulatory Updates You May Have Missed in February
Author(s)Courtney Flaherty
Fact checked by: Caroline Seymour, Kirsty Mackay
February brought key GI cancer updates: FDA approvals in BRAF+ mCRC and pancreatic cancer, plus new fast track and orphan designations.
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February featured an array of regulatory updates across gastrointestinal (GI) cancers. These included the FDA approval of encorafenib (Braftovi) plus cetuximab (Erbitux) and chemotherapy for BRAF V600E–mutant metastatic colorectal cancer (mCRC), and the approval of a first-of-its-kind noninvasive Tumor Treating Fields (TTFields) device, Optune Pax, for locally advanced pancreatic cancer. Additionally, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for perioperative durvalumab (Imfinzi) in gastric and gastroesophageal junction (GEJ) cancers.
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