India, Aug. 24 -- Jazz Pharmaceuticals plc (JAZZ) is set to face a pivotal FDA decision on August 25, 2026, for its drug candidate Ziihera.
Ziihera (zanidatamab-hrii) is a HER2-targeted bispecific antibody, originally developed by Zymeworks (ZYME) and now co-developed by Jazz and BeOne (ONC) under licensing agreements.
The FDA accepted Jaaz's supplemental Biologics License Application (sBLA) for Ziihera, supported by data from the pivotal HERIZON-GEA-01 Phase 3 study, which showed that Ziihera in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab, as a first-line treatment for adult patients with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction ...