Roche Gets CE Mark For First Companion Diagnostic To Identify HER2-low Metastatic Breast Cancer

(RTTNews) - Roche (RHHBY) said that it has received CE Mark approval for the VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx, enabling the identification of metastatic breast cancer patients with low HER2 expression who may benefit from ENHERTU (trastuzumab deruxtecan) as a targeted therapy.

The test, which is branded PATHWAY in the United States, received US Food and Drug Administration (FDA) approval in October 2022.

ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

HER2 is a receptor protein that helps cancer cells grow quickly. To determine a patient's HER2 status, pathologists evaluate, or score, the level of HER2 protein expressed in breast cancer tissue samples. If a patient's tumour expresses high levels of HER2, the patient is identified as HER2-positive and may be considered for HER2-targeted treatment. However, half of all patients with metastatic breast cancer express low levels of HER2 which historically classified them as HER2-negative.

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