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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Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.