Roche gets FDA approval for HER2 companion diagnostics in gastroesophageal cancer

Regulation
โดย PR Newswire·US·Read original
Summary · why it matters

Roche announced that the FDA has approved expanded use of its PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail tests as companion diagnostics to identify patients with HER2-positive metastatic gastroesophageal adenocarcinoma, including gastric, gastroesophageal junction, and esophageal adenocarcinoma, who may be eligible for treatment with Jazz Pharmaceuticals' ZIIHERA. This approval broadens the patient population eligible for HER2-targeted therapy, as previously no tests were approved to determine HER2 status in esophageal cancer. The tests, already widely used in breast and gastric cancers, are now part of Roche's comprehensive HER2 diagnostic portfolio, supporting personalized treatment approaches for this hard-to-treat disease.

Impact on stocks 4

Biotech & Genomic Medicine · 2 stocks
Jazz Pharmaceuticals PLC
JAZZ
▲ PositiveDemandrelevance

Approval expands use of companion diagnostics that identify patients eligible for Jazz's ZIIHERA, potentially increasing its market.

Health Care · 1 stocks
Roche Holding AG
ROP
▲ PositiveTechnologyrelevance

FDA approves expanded use of Roche's HER2 companion diagnostics, broadening its diagnostic portfolio.

Semiconductors · 1 stocks

Theme Impact 1

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