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

Posted: October 4, 2022 at 2:33 am

Basel, 4 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (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.

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

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