Gastrointestinal Cancer | Topics

FDA Grants Accelerated Approval to Pembrolizumab/Trastuzumab Combination for HER2+ Gastric/GEJ Cancers
May 05, 2021

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.

Ivosidenib Earns Priority Review for IDH1-Mutated Cholangiocarcinoma After Prior Therapy
May 05, 2021

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.

FDA Committee Does Not Support Maintaining Accelerated Approval of Nivolumab for Advanced HCC
April 30, 2021

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.