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# Priority Review for Jazz’s Zanidatamab Combo for Gastric Cancer
- URL: https://www.fdaweb.com/priority-review-for-jazzs-zanidatamab-combo-for-gastric-cancer/
- Published: 2026-04-27T12:00:00.000Z
- Updated: 2026-09-14T13:38:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161047

FDA has accepted for priority review a Jazz Pharmaceuticals supplemental BLA for Ziihera (zanidatamab-hrii) for use in combination regimens for first-line treatment of patients with HER2-positive advanced gastroesophageal cancers. The agency has set a user fee review target decision date of 8/25.

The filing seeks to expand the use of zanidatamab — already approved in the U.S. for certain biliary tract cancers — to include adults with HER2-positive unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinomas.

The application is supported by data from the Phase 3 HERIZON-GEA-01 trial, which evaluated zanidatamab in combination with chemotherapy, with or without the PD-1 inhibitor Tevimbra (tislelizumab). The study compared those regimens against the current standard of care, trastuzumab plus chemotherapy, in previously untreated patients with advanced HER2-positive disease, according to the company.

The trial results showed clinically meaningful improvements, including enhanced benefit when tislelizumab was added to zanidatamab and chemotherapy. Notably, the combination demonstrated activity regardless of PD-L1 status — an outcome that could broaden its applicability in this patient population, the company says.

“The HERIZON-GEA-01 trial results are practice-changing,” executive vice president and head of R&D at Jazz **Rob Iannone** says in a statement. He adds that the findings support zanidatamab as a potential “agent of choice” among HER2-targeted therapies in the first-line setting.

Zanidatamab is described as a bispecific antibody engineered to bind two distinct sites on the HER2 receptor, triggering multiple immune-mediated mechanisms that inhibit tumor growth and promote cancer cell death.

Gastroesophageal adenocarcinoma remains a major global health burden, ranking among the most common cancers worldwide, Jazz says. About 20% of cases are HER2-positive, a subgroup associated with aggressive disease and limited long-term survival.