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

Roche has announced that it has attained CE Mark approval for the VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx. This distinction means that medical professionals can now identify metastatic breast cancer patients with low HER2 expression who may potentially benefit from the targeted therapy of ENHERTU (trastuzumab deruxtecan).

This test, which is marketed as PATHWAY in the United States, was approved by the US Food and Drug Administration (FDA) in October 2022.

ENHERTU is a HER2-directed antibody drug conjugate specifically designed by Daiichi Sankyo and AstraZeneca. It is currently being jointly developed and commercialized by these entities.

To aid the rapid growth of cancer cells, the receptor protein HER2 is utilized. Determining a patient's HER2 status is done by pathologists who evaluate or score the level of HER2 protein occurring in breast cancer tissue samples. If a patient's tumor expresses high levels of HER2, they are deemed HER2-positive and might be considered for a HER2-targeted treatment. However, it's crucial to note that about half of all metastatic breast cancer patients have historically been classified as HER2-negative due to their low levels of HER2 expression.

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