Science
FDA expands approval of tests to identify patients eligible for Ziihera First approved test to determine HER2 status in esophageal cancer
Roche has received expanded U.S. Food and Drug Administration (FDA) approval for two diagnostic tests used to identify patients eligible for Jazz Pharmaceuticals’ Ziihera.
According to Fierce Biotech on the 27th (local time), Roche’s PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail can now be used in the United States to assess HER2-positive status in patients with metastatic gastroesophageal junction adenocarcinoma (GEA).
Eligible patients include those with gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
The expanded approvals coincide with an expanded indication for Ziihera.
Earlier this week, Ziihera received new FDA approval as a first-line treatment for HER2-positive gastric cancer.
In 2024, it was approved in the United States to treat adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer.
According to Roche, these cancers are generally aggressive and diagnosed late.
Roche said, “Until now, there has been no approved test to determine HER2 status in esophageal cancer, leaving patients unable to receive targeted treatment.”
The test approvals will enable physicians to identify patients most likely to benefit from Ziihera.
Biobook Team
biobookmedia@biobook.co.kr
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