Roche's PATHWAY Anti-HER2 (4B5) Test Gets FDA Approval To Identify Patients Eligible For ENHERTU

Swiss drug major Roche (RHHBY) announced Tuesday that the US Food and Drug Administration approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify metastatic breast cancer patients with low HER2 expression eligible for ENHERTU.

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

HER2 is a receptor protein that helps cancer cells grow quickly. 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.

Approximately half of all patients with metastatic breast cancer express low levels of HER2.

The company noted that 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 is the only FDA approved companion diagnostic indicated as an aid in the assessment of HER2 low status in metastatic breast cancer patients.

The 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.

Thomas Schinecker, CEO of Roche Diagnostics, said, "Previously, metastatic breast cancer patients with a lower level of HER2 expression were considered to be part of the HER2-negative population and had no HER2-targeted treatment options. Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes."

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