# ZIIHERA (zanidatamab-hrii) + fluoropyrimidine- and platinum-containing chemotherapy, with or without TEVIMBRA (tislelizumab-jsgr) PDUFA Event: First-line HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma

Canonical URL: https://biopharmsignal.com/pdufa-calendar/JAZZ/zanidatamab-combinations-her2-positive-gea

Ticker: JAZZ

Company: Jazz Pharmaceuticals

Event date: 2026-08-25

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-08-25

Application type: sBLA

FDA approved two first-line ZIIHERA regimens. FDA approved ZIIHERA with fluoropyrimidine- and platinum-containing chemotherapy plus TEVIMBRA for adults with...

## Event Timeline

### August 25, 2026 — FDA approved two first-line ZIIHERA regimens

FDA approved ZIIHERA with fluoropyrimidine- and platinum-containing chemotherapy plus TEVIMBRA for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. FDA also approved ZIIHERA with the same chemotherapy, without TEVIMBRA, for tumors that are IHC 3+. Both indications require an FDA-approved test.

[FDA — Approval of zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, GEJ and esophageal adenocarcinoma](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction)

### May 27, 2026 — HERIZON-GEA-01 results published in NEJM

The Phase 3 publication further characterized the survival benefit and safety of zanidatamab with chemotherapy, with or without tislelizumab, in first-line HER2-positive advanced GEA.

[Jazz Pharmaceuticals — HERIZON-GEA-01 publication update](https://investor.jazzpharma.com/news-releases/news-release-details/phase-3-herizon-gea-01-results-published-new-england-journal)

### April 27, 2026 — FDA accepted the sBLA with Priority Review

FDA accepted the application under Priority Review and Real-Time Oncology Review and assigned an August 25, 2026 target action date.

[Jazz Pharmaceuticals — FDA acceptance of the zanidatamab combinations sBLA](https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0/)

### November 17, 2025 — HERIZON-GEA-01 reported positive topline results

Zanidatamab plus chemotherapy improved progression-free survival versus trastuzumab plus chemotherapy, while the zanidatamab, tislelizumab and chemotherapy regimen improved both overall and progression-free survival.

[Jazz Pharmaceuticals — Positive Phase 3 HERIZON-GEA-01 results](https://investor.jazzpharma.com/news-releases/news-release-details/positive-herizon-gea-01-phase-3-results-support-ziiherar/)

### December 2, 2021 — Phase 3 HERIZON-GEA-01 study started

The pivotal first-line trial began evaluating zanidatamab with chemotherapy, with or without tislelizumab, in HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.

[ClinicalTrials.gov — HERIZON-GEA-01 study record (NCT05152147)](https://clinicaltrials.gov/study/NCT05152147)

## Regulatory Designations

- Priority Review FDA: [Jazz Pharmaceuticals — FDA acceptance and Priority Review](https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0/)

- Breakthrough Therapy FDA: [Jazz Pharmaceuticals — Breakthrough Therapy designation for first-line HER2-positive GEA](https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0/)

- Fast Track FDA: [Jazz Pharmaceuticals — Fast Track designation for first-line GEA](https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0/)

## Related Pages

- JAZZ PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/JAZZ.md

- JAZZ company profile: https://biopharmsignal.com/company/JAZZ.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md