BeOne Medicines: FDA grants Priority Review to sBLA for tevimbra/ziihera combo

BeOne Medicines (ONC) announced that the U.S. FDA has granted Priority Review to a supplemental Biologics License Application for tevimbra in combination with ziihera and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive gastric, gastroesophageal junction, or esophageal 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.