FDA Approves TEVIMBRA Combo for First-Line HER2-Positive Gastric Cancer
BeOne Medicines said the FDA approved TEVIMBRA with ZIIHERA and chemotherapy as a first-line treatment for HER2-positive gastroesophageal adenocarcinoma. Phase 3 results showed median overall survival of 26.4 months and progression-free survival of 12.4 months, including in PD-L1-negative tumors. The HERIZON-GEA-01 trial enrolled 914 patients. Management also raised revenue guidance after strong momentum, including a full-year forecast increase.