Posted by Michael Wonder on 30 Apr 2026
US FDA grants priority review to BeOne Medicines’ Tevimbra in first-line HER2 positive gastro-oesophageal adenocarcinoma
29 April 2026 - BeOne Medicines today announced that the US FDA has granted priority review to a supplemental biologics license application for Tevimbra (tislelizumab) in combination with Ziihera (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2 positive gastric, gastro-oesophageal junction, or oesophageal adenocarcinoma.
The FDA has also granted breakthrough therapy designation to the regimen of Ziihera in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without Tevimbra, in this indication.
