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Based on response data from a randomized phase 3 trial, the FDA granted accelerated approval to pembrolizumab plus trastuzumab and chemotherapy for the treatment of HER2-positive gastric tumors. 

FDA Grants Accelerated Approval to Pembrolizumab/Trastuzumab Combination for HER2+ Gastric/GEJ Cancers

Based on results of a phase 3 study, the IDH1-targeted agent ivosidenib will be considered by the FDA as therapy for cholangiocarcinoma following prior treatment. 

Ivosidenib Earns Priority Review for IDH1-Mutated Cholangiocarcinoma After Prior Therapy

By a close decision, the FDA’s Oncologic Drugs Advisory Committee voted against upholding the accelerated approval of nivolumab monotherapy to treat patients with hepatocellular carcinoma following sorafenib. 

FDA Committee Does Not Support Maintaining Accelerated Approval of Nivolumab for Advanced HCC 

Young women with gastrointestinal cancers who received the FOLFIRI or FOLFOX chemotherapy regimens experienced a benefit in terms of reduced nausea and vomiting with the combination of aprepitant plus palonosetron and dexamethasone.

Adding Aprepitant Combo to Chemotherapy Regimen Reduced CINV in Women With Gastrointestinal Cancer

A thought-provoking installment of Clinical Quandaries is presented by Alejandro Gabutti, MD; and Tommaso Cascella, MD, of a 36-year-old patient with hepatitis C virus-related cirrhosis and a subsequent diagnosis of hepatocellular carcinoma.

How to Radiologically Assess and Follow Response After Treatment of Hepatocellular Carcinoma 

Based on positive results of the phase 2 FIGHT trial, the FDA has granted the investigation antibody bemarituzumab plus FOLFOX6 breakthrough therapy designation for the treatment of locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma with FGFFR2b overexpression in the frontline setting.

FDA Grants Breakthrough Therapy Designation to Bemarituzumab for Frontline FGFR2b+ Gastric/GEJ Cancers 

Twenty percent of patients with resectable hepatocellular carcinoma experienced significant tumor necrosis when treated with neoadjuvant cemiplimab-rwlc, according to data from a phase 2a open label.

Complete Pathological Responses Seen for Resectable HCC Treated With Neoadjuvant Cemiplimab

The addition of nivolumab to either chemotherapy or ipilimumab improved overall survival among patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, according to data from the phase 3 CheckMate-648 trial.

Addition of Nivolumab Improves OS in Patients with Unresectable, Advanced ESCC

Phase 2 trial data support the FDA breakthrough therapy designation for futibatinib in cholangiocarcinoma tumors positive for FGFR2 gene fusions and rearrangements.

Futibatinib Earns Breakthrough Therapy Designation for FGFR2+ Cholangiocarcinoma

The phase 3 CheckMate 577 trial is the first to show a checkpoint inhibitor in the adjuvant setting after trimodality therapy demonstrate a statistically significant and clinically meaningful improvement in disease-free survival in patients with resected esophageal and gastroesophageal junction cancer.

Gastrointestinal Cancer | Topics