Medicine

FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which identifies patients with HR–positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with Enhertu.

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