FDA Expands Labels For Roche's HER2 Tests, Enabling Identification Of All HER2-Positive Metastatic Breast Cancer Patients Eligible For ENHERTU

• FDA expands labels for Roche's PATHWAY HER2 (4B5) test* and VENTANA HER2 Dual ISH DNA Probe Cocktail, which can now be used to identify HER2-positive metastatic breast cancer patients that could be eligible for ENHERTU.
  
  
  
   
• 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 had been approved for identifying mBC patients with HER2-low and HER2-ultralow expression. With this expanded approval, Roche's PATHWAY HER2 (4B5) test in combination with the VENTANA HER2 Dual ISH DNA Probe Cocktail can now be used to identify patients across the full spectrum of HER2 expression for potential eligibility for ENHERTU. This approval reflects the vital role of advanced diagnostics in guiding precise treatment decisions to address the diverse needs of mBC patients.