25/08/2026 US FDA approves zanidatamab combination therapy in HER2+ GEA US FDA approves zanidatamab combination therapy in HER2+ GEA (Ref) The US FDA has approved Jazz, BeOne and Zymeworks' Ziihera (zanidatamab-hrii; bispecific HER2-directed antibody) with and without BeOne's tislelizumab (anti-PD-1) + chemotherapy for first-line treatment of HER2+ advanced gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status Approval was supported by Phase 3 HERIZON-GEA-01 trial

27/04/2026 Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDUFA date of Aug'26 set Tovecimig + paclitaxel significantly improved PFS and ORR in biliary tract cancer; sBLA submission planned FDA Grants Breakthrough Therapy Designation to TERN-701 in Chronic Myeloid Leukemia Relay Therapeutics Advances PI3Kα/CDK4 Triplet Toward Frontline Breast Cancer Phase 3 Trial Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDU