Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA
Roche has received FDA approval for its PATHWAY HER2 (4B5) test as the first companion diagnostic for identifying biliary tract cancer (BTC) patients eligible for HER2-targeted treatment with ZIIHERA. The test helps identify patients with previously-treated, unresectable or metastatic HER2-positive BTC who may benefit from ZIIHERA treatment. This represents a significant advancement as BTC has treatment options, with most cases diagnosed at advanced stages. The test's approval expands its clinical utility and provides a standardized method for identifying eligible patients for targeted therapy. BTC accounts for 3% of gastrointestinal cancers in the US, with a five-year survival rate of only 19% for localized disease and 3% for metastatic cases.
Roche ha ricevuto l'approvazione della FDA per il suo test PATHWAY HER2 (4B5) come primo diagnostico accompagnatorio per identificare i pazienti con cancro delle vie biliari (BTC) idonei al trattamento mirato con ZIIHERA. Il test aiuta a identificare i pazienti con BTC HER2-positivo precedentemente trattato, non resecabile o metastatico, che potrebbero trarre beneficio dal trattamento con ZIIHERA. Ciò rappresenta un avanzamento significativo, dato che il BTC ha poche opzioni di trattamento, con la maggior parte dei casi diagnosticati in fasi avanzate. L'approvazione del test ne espande l'utilità clinica e fornisce un metodo standardizzato per identificare i pazienti idonei per la terapia mirata. Il BTC rappresenta il 3% dei tumori gastrointestinali negli Stati Uniti, con un tasso di sopravvivenza a cinque anni del solo 19% per le malattie localizzate e del 3% per i casi metastatici.
Roche ha recibido la aprobación de la FDA para su prueba PATHWAY HER2 (4B5) como el primer diagnóstico acompañante para identificar a pacientes con cáncer de vías biliares (BTC) elegibles para tratamiento dirigido con ZIIHERA. La prueba ayuda a identificar a pacientes con BTC HER2-positivo previamente tratados, no resecables o metastásicos que pueden beneficiarse del tratamiento con ZIIHERA. Esto representa un avance significativo, ya que el BTC tiene pocas opciones de tratamiento, siendo la mayoría de los casos diagnosticados en etapas avanzadas. La aprobación de la prueba amplía su utilidad clínica y proporciona un método estandarizado para identificar a los pacientes elegibles para terapia dirigida. El BTC representa el 3% de los cánceres gastrointestinales en EE. UU., con una tasa de supervivencia a cinco años del solo 19% para la enfermedad localizada y del 3% para casos metastásicos.
로슈는 FDA 승인을 받았습니다 PATHWAY HER2 (4B5) 테스트가 ZIIHERA와 함께 HER2 표적 치료를 받을 수 있는 담관암 (BTC) 환자를 식별하기 위한 첫 번째 동반 진단으로 승인되었습니다. 이 테스트는 이전에 치료를 받은 비절제성 또는 전이성 HER2 양성 BTC 환자를 식별하는 데 도움이 되며, 이들은 ZIIHERA 치료의 혜택을 받을 수 있습니다. 이는 BTC가 치료 옵션이 적고 대부분의 경우가 진행된 단계에서 진단되는 점에서 중요한 발전을 의미합니다. 테스트의 승인은 임상적 유용성을 확장하고 표적 치료를 받을 수 있는 환자를 식별하기 위한 표준화된 방법을 제공합니다. BTC는 미국의 위장관 암의 3%를 차지하며, 국소 질환의 경우 5년 생존율은 단 19%, 전이성 경우에는 3%에 불과합니다.
Roche a reçu l'approbation de la FDA pour son test PATHWAY HER2 (4B5) en tant que premier diagnostic compagnon pour identifier les patients atteints de cancer des voies biliaires (BTC) éligibles à un traitement ciblé HER2 avec ZIIHERA. Le test aide à identifier les patients atteints de BTC HER2-positif précédemment traités, non résécables ou métastatiques qui pourraient bénéficier du traitement avec ZIIHERA. Cela représente une avancée significative car le BTC a peu d'options de traitement, la plupart des cas étant diagnostiqués à un stade avancé. L'approbation du test élargit son utilité clinique et fournit une méthode standardisée pour identifier les patients éligibles à une thérapie ciblée. Le BTC représente 3% des cancers gastro-intestinaux aux États-Unis, avec un taux de survie à cinq ans de seulement 19% pour les maladies localisées et de 3% pour les cas métastatiques.
Roche hat die FDA-Zulassung für seinen PATHWAY HER2 (4B5)-Test als erstes begleitendes diagnostisches Verfahren zur Identifizierung von Patienten mit Gallengangskrebs (BTC), die für eine HER2-zielgerichtete Behandlung mit ZIIHERA in Frage kommen, erhalten. Der Test hilft dabei, Patienten mit zuvor behandelten, nicht operablen oder metastasierten HER2-positiven BTC zu identifizieren, die von der Behandlung mit ZIIHERA profitieren könnten. Dies stellt einen bedeutenden Fortschritt dar, da BTC nur wenige Behandlungsmöglichkeiten hat und die meisten Fälle in fortgeschrittenen Stadien diagnostiziert werden. Die Zulassung des Tests erweitert dessen klinische Nützlichkeit und bietet eine standardisierte Methode zur Identifizierung geeigneter Patienten für die zielgerichtete Therapie. BTC macht 3% der gastrointestinalen Krebserkrankungen in den USA aus, mit einer fünfjährigen Überlebensrate von nur 19% bei lokalisierten Erkrankungen und 3% bei metastasierten Fällen.
- First FDA-approved companion diagnostic test for BTC HER2 testing
- Expands market opportunity for existing PATHWAY HER2 test
- Opens new revenue stream in BTC diagnostic market
- Creates competitive advantage as only FDA-approved test in this indication
- market size (BTC represents only 3% of gastrointestinal cancers)
- Test restricted to specific patient subset (HER2-positive BTC only)
- The PATHWAY HER2 (4B5) test helps to identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.
- There are currently very few options for BTC patients as most cases are at an advanced stage at the time of diagnosis.
- This approval represents a new indication for Roche's existing PATHWAY HER2 (4B5) test and expands its clinical utility by broadening the scope of patients who are eligible for HER2-targeted therapies.
HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.1 No approved and validated HER2 test existed to identify eligible BTC patients until the approval of this expanded label for the PATHWAY HER2 (4B5) test.
"This test is a step forward in furthering access to personalised medicine," said Jill German, Head of Pathology Lab at Roche Diagnostics. "The prognosis for patients diagnosed with BTC is poor, as very few treatment options exist. Now, these patients have access to the first standardised test that could make them eligible for targeted therapy, potentially improving clinical outcomes."
ZIIHERA is the first FDA-approved treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.
BTC accounts for
About the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody
The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody delivers timely, clear and reliable results, enabling therapeutic decisions that can lead to better outcomes for patients. Already indicated as an aid to identify breast cancer patients eligible for HER2-targeted treatment with Herceptin®, KADCYLA®, or ENHERTU®,7 the test is used in combination with the fully automated VENTANA® BenchMark slide staining instrument. The introduction of the new indication for BTC represents a significant expansion of the test's clinical utility. The assay forms an important part of Roche's comprehensive gastrointestinal cancer solutions portfolio, which is aimed at driving diagnostic certainty for life-changing decisions in cancer care.
The assay standardises all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error.8 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 clones9 and demonstrates high concordance with HER2 FISH,10,11 empowering laboratories to employ the most widely adopted and reliable HER2 IHC primary antibody.
For more information about the portfolio, please visit the Roche Diagnostics Pathology Lab companion diagnostics page.
About Roche
Founded in 1896 in
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.
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For more information, please visit www.roche.com.
* Hereafter referred to as PATHWAY HER2 (4B5) test |
References
[1] Yoon, J., Oh, DY. Nat Rev Clin Oncol 21, 675–700 (2024)
[2] Harding, J. et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZONBTC-01): a multicentre, single-arm, phase 2b study. Lancet Oncol 2023; 24: 772–82.
[3] Scott, A. et al. Precision Medicine in Biliary Tract Cancer. J Clin Oncol 2022 40:2716-2734.
[4] Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Biliary Tract Cancer V.2.2024. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved.
[5] Valle JW, Kelley RK, Nervi B, Oh D-Y, Zhu AX. Biliary tract cancer. Lancet 2021; 397: 428–44.
[6] Nakanuma Y, Kakuda Y: Pathologic classification of cholangiocarcinoma: New concepts. Best Pract Res Clin Gastroenterol 29:277-293, 2015
[7] PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, US Package Insert (D197603 Rev 1). 2024.
[8] VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx Package Insert, 2024.
[9] NordiQC Assessments
[10] 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.
[11] 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.
Roche Media Relations
Jo Lynn Garing
Phone: +1 317-363-7286
Email: jo_lynn.garing@roche.com
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