GI Cancers | Clinical

FDA Approves 1L Pembrolizumab Combination in Locally Advanced Unresectable or Metastatic HER2+ Gastric/GEJ Cancers

May 05, 2021

The FDA has granted accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction cancer.

FDA Grants Breakthrough Therapy Designation to Bemarituzumab for Select FGFR2b+/HER2- Advanced Gastric and GEJ Cancers

April 20, 2021

The FDA has granted breakthrough therapy designation to bemarituzumab for the first-line treatment of patients with HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma who harbor FGFR2b overexpression or amplification.

FDA Lifts Partial Clinical Hold from Study of SBP-101 in Pancreatic Cancer

April 16, 2021

The FDA has lifted a partial clinical hold on a phase 1 clinical trial of SBP-101 in combination with the standard-of-care agents gemcitabine and nab-paclitaxel as treatment of patients with metastatic pancreatic ductal adenocarcinoma.