GI CANCERS

The supplemental biologics license application is supported by the phase 3 ATOMIC trial.

FDA clears automated PD-L1 22C3 testing on Dako Omnis for 4 more tumors, streamlining labs and guiding Keytruda therapy decisions.

"These findings may be considered practice changing for medical oncologists treating HCC globally,” said Vishwanath Sathyanarayanan, MD.

FDA opens expanded access to daraxonrasib for metastatic pancreatic cancer, as phase 3 data boost survival and clinics race to manage access hurdles.

The FDA has granted suplexa, a non-engineered autologous cellular immunotherapy, fast track designation for patients with MSI-H colorectal cancer.

During a live event, Ronan J. Kelly, MD, MBA, and participants discussed how they use PD-1 inhibitors in patients with upper gastrointestinal cancers.

The DLL3-targeting antibody-drug conjugate zocilurtatug pelitecan has elicited antitumor activity across subtypes of extrapulmonary neuroendocrine carcinomas.

The FDA has approvesd zenocutuzumab-zbco for previously treated NRG1 fusion–positive cholangiocarcinoma cholangiocarcinoma.

The FDA previously granted RZ-001 both orphan drug designation and fast track designation for hepatocellular carcinoma.

The phase 1/2 data led to the phase 3 RASolute 302 trial which supported the FDA's allowance of early access to daraxonrasib in PDAC.

Shagufta Shaheen, MD, discusses treatment strategies for pancreatic NETs.

Pelareorep plus FOLFIRI and bevacizumab showed durable responses in second-line RAS-mutant MSS metastatic colorectal cancer.

The FDA has authorized expanded access to the RAS inhibitor daraxonrasib for patients with previously treated metastatic pancreatic ductal adenocarcinoma.

Expert insights from Shagufta Shaheen, MD, on sequencing PRRT, everolimus, and cabozantinib after SSA progression in advanced GI NETs, balancing PFS gains and tolerability.

During a live event, Ronan J. Kelly, MD, MBA, and participants discussed key considerations for biomarker testing in upper GI cancers.

The COMPANION-002 trial in biliary tract cancer allowed crossover to the tovecimig arm which likely confounded overall survival data.

The FDA has has granted a priority review to zanidatamab-based regimens for the first-line treatment of patients with gastroesophageal adenocarcinoma.

BBO-11818 has received FDA fast track designation for KRAS-mutant pancreatic cancer, with early phase 1 data showing antitumor activity.

Combination of interleukin-12 therapy with HAIP chemotherapy showed strong antitumor activity and manageable safety in metastatic CRC with liver metastases.

FDA reviews new zenocutuzumab bid for NRG1 fusion cholangiocarcinoma and NCCN adds new recommendations for use of the bispecific antibody.

During a live event, Mark Yarchoan, MD and participants weighed new phase 3 immunotherapy combos for unresectable HCC, balancing survival gains, response durability, and real‑world toxicity challenges.

Daraxonrasib nearly doubled median OS vs chemotherapy in pretreated metastatic pancreatic cancer, per phase 3 RASolute 302 trial data.

Tovecimig plus paclitaxel lifts response rates in second-line biliary tract cancer, prompting FDA orphan status and advancing a potential new option.

New trial data show adding durvalumab/tremelimumab and lenvatinib to TACE delays progression in unresectable HCC, hinting at longer survival.

The oral FGFR2 inhibitor lirafugratinib is being reviewed by the FDA for the second-line treatment of cholangiocarcinoma harboring FGFR2 alternations.