Posted by Michael Wonder on 03 Feb 2025
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2 ultralow metastatic breast cancer eligible for Enhertu
31 January 2025 - The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2 low status since 2022, is now also approved to aid in the assessment of HER2 ultralow status for metastatic breast cancer patients.
Roche announced today that the US FDA has approved a label expansion for the PATHWAY anti-HER2/neu (4B5) rabbit monoclonal primary antibody to identify patients with HR-positive, HER2 ultralow metastatic breast cancer who may be eligible for treatment with Enhertu.
