Roche Expands FDA Approval of PATHWAY® HER2 Test for HER2-Ultralow Breast Cancer Status

Roche Expands FDA Approval of PATHWAY® HER2 Test for HER2-Ultralow Breast Cancer Status

(IN BRIEF) Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HER2-ultralow status in HR-positive, HER2-negative metastatic breast cancer patients. This new approval offers a potential treatment option for this previously underserved group, helping patients gain access to HER2-targeted therapies such as ENHERTU®. The expansion builds on the success of the HER2-low category and follows positive results from the DESTINY-Breast06 trial, where ENHERTU showed significant benefits in both HER2-low and HER2-ultralow patients. Roche continues to strengthen its breast cancer diagnostic solutions, providing more opportunities for personalized treatments.

(PRESS RELEASE) BASEL, 1-Feb-2025 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label for its PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. This new approval allows the test to identify HER2-ultralow status in patients with HR-positive, HER2-negative metastatic breast cancer, a critical step in providing these patients with access to targeted treatments, such as ENHERTU®.

This approval marks a significant milestone in HER2 diagnostics, extending beyond the existing HER2-low category, which was introduced in 2022. HER2-ultralow refers to even lower levels of HER2 expression, representing a previously under-recognized patient population that may benefit from HER2-targeted therapy. This expansion could significantly impact patient outcomes by offering a path to treatment where previously no options existed.

“The growing incidence of metastatic breast cancer, especially among younger women, highlights the need for innovative diagnostic solutions,” said Matt Sause, CEO of Roche Diagnostics. “Our PATHWAY HER2 (4B5) test’s FDA approval for HER2-ultralow status brings hope to patients and offers clinicians a new tool to transform outcomes, by identifying individuals who may benefit from HER2-targeted therapies like ENHERTU.”

Roche’s PATHWAY HER2 (4B5) test was a key component in the DESTINY-Breast06 trial, which demonstrated the significant benefits of ENHERTU for HER2-low and HER2-ultralow metastatic breast cancer patients. The trial showed a median progression-free survival of 13.2 months for patients treated with ENHERTU, compared to 8.1 months for those receiving standard chemotherapy. Notably, the results were consistent across patients in both the HER2-low and HER2-ultralow groups.

This expanded indication builds on Roche’s legacy in breast cancer diagnostics and strengthens its comprehensive portfolio aimed at improving outcomes for breast cancer patients. By making this diagnostic tool available, Roche continues to lead efforts in transforming treatment approaches, offering more patients a targeted treatment option that was previously unavailable.

For more details on the PATHWAY HER2 (4B5) test and its capabilities, visit Roche’s website.

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.3 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 4 and demonstrates high concordance with HER2 FISH,5,6 empowering laboratories to employ the most widely adopted and reliable HER2-IHC primary antibody.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

* Hereafter referred to as PATHWAY HER2 (4B5) test

All trademarks used or mentioned in this release are protected by law.

References
[1] Salgado RF, et al. LBA21 – Human epidermal growth factor receptor 2 (HER2)-low and HER2-ultralow status determination in tumors of patients (pts) with hormone receptor–positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). Annals of Oncology. (2024) 35 (suppl_2): 1-72. 10.1016/annonc/annonc1623.
[2] Bardia A, et. al. Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer, New England Journal of Medicine. 2024; 391:2110-2122
[3] PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Package Insert
[4] NORDIQC HER2 IHC Assessment Run B37 2024
[5] Mayr D, et al. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest™ (Dako) for manual testing and Her-2/neuTest 4B5 (VENTANA) for VENTANA BenchMark automatic staining system with correlation to results of BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Archiv. 2009; 454(3):241–248.
[6] Brügmann A, Lelkaitis G, Nielsen S, et al. Testing HER2 in breast cancer: a comparative study on BRISH, FISH, and IHC. Appl Immunohistochem Mol Morphol. 2011;19(3):203-211.

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SOURCE: Roche