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Roche Nabs FDA Approval for CDx With Ziihera in Gastroesophageal Cancer

Published

26 August 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at 360dx.com →

◆ Verified

Fusion42 · 26 August 2026 · Fusion42 review

Roche received FDA approval for expanded use of two companion diagnostic tests with Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) in treating metastatic gastroesophageal adenocarcinoma.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ ◆ The Wire takeaway

Medtech founders targeting gastroesophageal cancer markets must fast-track regulatory strategies as diagnostic approvals are opening new patient stratification paths that can accelerate therapy adoption and partnerships.

◆ Coverage

1 source · 26 Aug 2026

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◆ Topics

Medtechfda-approvalcompanion-diagnosticsgastroesophageal-cancerrochezanidatamab