Roche gets FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
Roche announced Monday that the U.S. Food and Drug Administration (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®.