Health
Roche receives FDA approval for first diagnostic tests to identify HER2-positive metastatic breast cancer patients eligible for ENHERTU
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved additional indications for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA HER2 Dual ISH DNA Probe Cocktail tests. These tests are now approved to aid in identifying HER2-positive metastatic breast cancer (mBC) patients who may be eligible for treatment with ENHERTU® (trastuzumab deruxtecan), a specifically engineered HER2-directed antibody drug conjugat
About this update from Roche Holding Ltd
[{"type":"list","items":[{"val":[{"type":"text","content":"FDA expands labels for Roche's PATHWAY HER2 (4B5) test* and VENTANA HER2 Dual ISH DNA Probe Cocktail, which can now be used to identify HER2-positive metastatic breast cancer patients that could be eligible for ENHERTU.","length":228,"tagName":"p"}]},{"val":[{"type":"text","content":"Roche's PATHWAY HER2 (4B5) test is the only test approved to identify all levels of HER2 expression.","length":104,"tagName":"p"}]},{"val":[{"type":"text","content":"Roche's breast cancer diagnostic portfolio now provides clinicians with a comprehensive solution to assess HER2 expression and guide treatment decisions for this challenging disease.","length":186,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":518,"olType":false},{"type":"text","content":"TUCSON, Ariz., Dec. 15, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved additional indications for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA HER2 Dual ISH DNA Probe Cocktail tests. These tests are now approved to aid in identifying HER2-positive metastatic breast cancer (mBC) patients who may be eligible for treatment with ENHERTU® (trastuzumab deruxtecan), a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.","length":663,"tagName":"p"},{"type":"image","alt":"Roche (PRNewsfoto/Roche | Diagnostics Information)","displaySize":"","headline":null,"caption":"Roche (PRNewsfoto/Roche | Diagnostics Information)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":273,"url":"https://media.zenfs.com/en/prnewswire.com/953d19336df96f7f01d1d706215d51c6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/YG4v0C.buoLkHpHXpC_sCg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ4MTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/953d19336df96f7f01d1d706215d51c6","width":400,"height":273}},"href":"https://mma.prnewswire.com/media/2845923/Roche_Pantone_coated_v2.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Until now, Roche's PATHWAY HER2 (4B5) test had been approved for identifying mBC patients with HER2-low and HER2-ultralow expression. With this expanded ...