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Optune Pax Is Approved in Japan for Unresectable Locally Advanced Pancreatic Cancer
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Results from an early-stage clinical trial found encouraging outcomes in newly diagnosed pancreatic cancer that had spread to distant organs.

Read a refresh of GI cancer FDA news from August 2026, including the approval of a RAS(ON) inhibitor in metastatic pancreatic cancer.

The FDA has approved lirafugratinib (Lyrfigtu) for the treatment of adult patients with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 gene fusion or other rearrangement.

Lanreotide injection, a generic formulation referencing lanreotide, was approved by the FDA for GEP-NETs management.

The FDA granted final approval to Lutetium Lu 177 dotatate biosimilar for patients with SSTR-positive GEP-NETs.

The FDA approved imlunestrant plus abemaciclib in breast cancer and photodynamic therapy in skin cancer, and more.

Did you catch all of this week's top oncology news? Test your knowledge with OncLive's Weekly News Quiz.

A marketing authorization application for lirafugratinib in previously treated FGFR2-altered metastatic cholangiocarcinoma has been submitted to the EMA.

Daraxonrasib plus gemcitabine and nab-paclitaxel received FDA breakthrough therapy designation for treatment-naive metastatic pancreatic adenocarcinoma.

The FDA has approved lutetium Lu 177 dotatate injection for SSTR-positive GEP-NETs, including foregut, midgut, and hindgut NETs.

The FDA approved sevabertinib in first-line HER2-mutant lung cancer, durvalumab plus tarlatamab boosted survival in ES-SCLC, and more.

OS in the LIVERATION trial of namodenoson in advanced HCC appeared longer than anticipated, prompting consideration of an earlier interim analysis.

The top 5 OncLive TV videos of the week cover insights in essential thrombocythemia, CML, pancreatic cancer, myelofibrosis, and chronic neutropenia.

A pharmacokinetic sub-study found that TAMP-mediated gemcitabine reduced systemic drug exposure in patients with locally advanced pancreatic cancer.

Here is your cheat sheet to all therapeutic options that were cleared by the FDA in August 2026 spanning tumor types.

The zanidatamab-plus-chemotherapy arm met its overall survival end point at the second interim analysis of the phase 3 HERIZON-GEA-01 trial.

The top 5 OncLive TV videos of the week cover pancreatic cancer, gastric cancer, GIST, renal cell carcinoma, and chronic lymphocytic leukemia.

The FDA approved daraxonrasib for pancreatic cancer, cleared zanidatamab-based regimens for HER2-positive gastric cancer, and more.

Did you catch all of this week's top oncology news? Test your knowledge with OncLive's Weekly News Quiz.

The conditional approval of fanregratinib is supported by pivotal phase 2 data showing a 42.5% objective response rate in pretreated FGFR2-altered intrahepatic cholangiocarcinoma.

The FDA approval of daraxonrasib was based on data from the phase 3 RASolute 302 trial in previously treated metastatic pancreatic ductal adenocarcinoma.

Ivonescimab plus chemotherapy significantly improved overall survival vs durvalumab plus chemotherapy in advanced biliary tract cancer.

FDA Approves Zanidatamab-Based Regimens for First-Line HER2+ Locally Advanced or Metastatic Gastric Cancer
The FDA has approved zanidatamab plus chemotherapy with/without tislelizumab in frontline HER2-positive GEA based on data from HERIZON-GEA-01.

The oral pan-RAS molecular glue ERAS-0015 has received FDA fast track designation for the management of metastatic pancreatic adenocarcinoma.























































































