Category: Approval/Launch Region: Europe · Switzerland Company: Roche Holding Ag

Roche gets US FDA nod for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for Enhertu

Roche gets US FDA nod for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for Enhertu
Roche announced that the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. HER2 is a receptor protein that helps cancer cells grow quickly. To determine a patient

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