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FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for Enhertu

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Published:4th Oct 2022

Roche announced that the 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’s HER2 status, pathologists evaluate, or score, the level of HER2 receptor 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.

The PATHWAY anti-HER2 (4B5) test now includes a scoring algorithm that helps pathologists to identify “low expressors” of HER2, assigning a HER2 low status to this group of patients. With this lower cutoff, the test is able to identify patients who may benefit from Enhertu as a treatment option.

The PATHWAY anti-HER2 (4B5) test was used as part of the DESTINY-Breast04 trial sponsored by AstraZeneca and Daiichi Sankyo to identify patients whose tumours expressed low levels of HER2 protein. The trial reported a 50% reduction in the risk of disease recurrence or death and an overall gain of six months over standard of care in patients treated with Enhertu whose tumours had low levels of HER2 expression.

About PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Antibody: Roche’s pre-diluted PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, used in combination with the fully automated BenchMark IHC/ISH slide staining instrument, standardises all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error. It also minimises inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The Roche HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones and demonstrates high concordance with HER2 FISH, empowering laboratories to employ the most widely adopted and reliable. HER2-IHC primary antibody.

Condition: Breast Cancer/HER 2 low
Type: drug

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