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StocksMediumUpdated•Originally published 27 April 2026•Updated 29 April 2026•

1 min read

FDA Grants Priority Review for Jazz Pharmaceuticals' Ziihera Combination

Key Facts

1The U.S. FDA accepted the supplemental Biologics License Application for Ziihera with Priority Review status.

2The FDA has set a PDUFA target action date of August 25, 2026, for the regulatory decision.

Jazz Pharmaceuticals announced that the U.S. FDA has accepted a supplemental Biologics License Application (sBLA) for Ziihera, granting it Priority Review status. It has been clarified that BeOne Medicines is the applicant for the combination of TEVIMBRA (tislelizumab) with ZIIHERA and chemotherapy. This therapeutic regimen is intended for first-line use in patients with HER2-positive gastric or gastroesophageal junction cancers. The FDA has established a PDUFA target action date of August 25, 2026, for its final regulatory decision. Priority Review designation is designed to accelerate the evaluation of therapies that offer significant improvements in treating serious medical conditions. This milestone underscores the clinical potential of the combination therapy within the oncology landscape.

about 1 month ago

Version History

Version 1about 1 month ago

What changed: Identified BeOne Medicines as the applicant and included TEVIMBRA as the specific drug used in combination with ZIIHERA.