Roche receives FDA approval for first diagnostic tests to identify HER2-positive metastatic breast cancer patients eligible for ENHERTU [Yahoo! Finance]
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Yahoo! Finance
Roche's PATHWAY HER2 (4B5) test is the only test approved to identify all levels of HER2 expression. Roche's breast cancer diagnostic portfolio now provides clinicians with a comprehensive solution to assess HER2 expression and guide treatment decisions for this challenging disease. TUCSON, Ariz. Dec. 15, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved additional indications for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA HER2 Dual ISH DNA Probe Cocktail tests. These tests are now approved to aid in identifying HER2-positive metastatic breast cancer (mBC) patients who may be eligible for treatment with ENHERTU ® (trastuzumab deruxtecan), a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca. Until now, Roche's PATHWAY HER2 (4B5) test h
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