ENHERTU
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Roche Receives CE-IVDR Approval for HER2 Companion Diagnostic Identifying HER2-Ultralow Breast and Biliary Tract Cancer Patients
Roche’s VENTANA HER2 (4B5) test received CE-IVDR approval for expanded use in breast and biliary tract cancers. It’s the first companion diagnostic to identify HR-positive metastatic breast cancer patients with HER2-ultralow expression potentially eligible for ENHERTU treatment. It’s also approved to identify previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) patients who may be eligible for ZIIHERA. This strengthens Roche’s position in personalized cancer treatment, offering more targeted options for patients.