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In a 6 to 2 vote, the FDA’s Oncologic Drugs Advisory Committee voted against maintaining the accelerated approval of pembrolizumab for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more lines of therapy.

The combination of atezolizumab and bevacizumab has become the frontline standard of care for most patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

Amgen has completed its planned acquisition of Five Prime Therapeutics for $38.00 per share in cash, or approximately $1.9 billion.

After years of stagnation, the paradigm for treating patients with unresectable intermediate-stage or advanced hepatocellular carcinoma is starting to change as a result of novel strategies and evolving views of appropriate patient populations for systemic therapies.

Riad Salem, MD, discusses the unique elements of the TheraSphere, the data that supported the regulatory approval, and the anticipated future for the radioembolization technology in hepatocellular carcinoma.


The FDA’s Oncologic Drugs Advisory Committee is poised to move forward this week with a public review of 6 indications for immune checkpoint inhibitors granted under the agency’s accelerated approval process that later failed to reach thresholds for statistical significance for key end points in confirmatory clinical trials.

With immunotherapy options expanding for patients with a range of gastrointestinal cancers to include combination strategies with chemotherapy, their use in the treatment course should come sooner rather than later for those with high PD-L1 expression.

The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.

The plethora of actionable targets in intrahepatic cholangiocarcinoma has created opportunities for these patients to be treated with targeted therapy.

Anita Lavery, MD, MRCP, discusses achieving safe care for patients with esophagogastric cancer during the COVID-19 pandemic.

Parissa Tabrizian, MD, discusses the rationale for examining cemiplimab in hepatocellular carcinoma.

Moores Cancer Center at UC San Diego Health is among the few clinical trial sites in the U.S. for the Pancreatic Cancer Action Network’s newly created Precision Promise, the first large-scale precision medicine trial designed to transform outcomes for patients with pancreatic cancer.

Zev A. Wainberg, MD, discusses the role of neoadjuvant chemotherapy in resectable pancreatic cancer, emerging approaches in locally advanced disease, the promise of PARP inhibitors in the metastatic setting, and other future research directions of interest.

Derazantinib demonstrated promising disease control when given to patients with inoperable or advanced intrahepatic cholangiocarcinoma and FGFR2 gene fusion.

Investigators are exploring a dual HER2-targeting strategy that incorporates tucatinib into a novel combination as second-line therapy for patients with HER2-positive gastric and esophageal cancers.

The FDA has granted a breakthrough therapy designation to bemarituzumab plus modified fluoropyrimidine, leucovorin, and oxaliplatin as a frontline treatment for patients with FGFR2b–overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma.

Milind Javle, MD, of The University of Texas MD Anderson Cancer Center, explains what GI oncologists can expect from FGFR treatment for advanced cholangiocarcinoma in terms of treatment responses.

Recommendations for appropriately managing patients who experience adverse events associated with FGFR treatment for advanced cholangiocarcinoma.

Siddharth Padia, MD, discusses the data that led to the March 2021 FDA approval of TheraSphere™ Yttrium-90 Glass Microspheres for use in patients with hepatocellular carcinoma.

Yoomi Lee, MD, discusses the safety profile of surufatinib and highlighted future directions for patients with pancreatic and extrapancreatic NETs.

The FDA has approved nivolumab to be combined with select types of chemotherapy for the frontline treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

Although anticancer therapies that leverage T cells have commanded the most attention in the immuno-oncology era of the past decade, strategies based on natural killer cells have recently emerged as attractive approaches.

Raymond Wadlow, MD, discusses the emergence of combination chemotherapy regimens in metastatic pancreatic cancer and the promise of emerging strategies that are under exploration.

Katelyn M. Atkins, MD, PhD, discusses the role of adjuvant chemoradiation therapy in gastric cancer.









































