Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY
Roche has received FDA approval for the VENTANA CLDN18 (43-14A) RxDx Assay, the first companion diagnostic to identify patients with gastric and gastroesophageal junction (GEJ) cancer eligible for targeted treatment with VYLOY. This immunohistochemistry (IHC) assay helps determine CLDN18 protein expression in tumors, enabling clinicians to identify patients who may benefit from Astellas' targeted therapy VYLOY (zolbetuximab).
The assay addresses an unmet medical need by helping predict the likelihood of response to targeted therapy in gastric and GEJ cancers. CLDN18.2 is an emerging biomarker in these cancers. This approval aligns with current guidelines recommending biomarker use to guide therapeutic decision-making in gastric/GEJ cancer.
Gastric cancer is the fifth most common cancer and fourth leading cause of cancer deaths worldwide. In the U.S., 62% of gastric/GEJ cancer cases are advanced at initial diagnosis, with a five-year overall survival rate of only 6%.
Roche ha ricevuto l'approvazione dalla FDA per il VENTANA CLDN18 (43-14A) RxDx Assay, il primo test diagnostico companion per identificare i pazienti affetti da cancro gastrico e cancer del giunzione gastroesofagea (GEJ) idonei per un trattamento mirato con VYLOY. Questo test di immunoistochimica (IHC) aiuta a determinare l'espressione della proteina CLDN18 nei tumori, consentendo ai medici di identificare i pazienti che potrebbero beneficiare della terapia mirata VYLOY (zolbetuximab).
Il test risponde a un bisogno medico insoddisfatto prevedendo la probabilità di risposta alla terapia mirata nei tumori gastrici e GEJ. CLDN18.2 è un biomarcatore emergente in questi tipi di cancro. Questa approvazione è in linea con le attuali linee guida che raccomandano l'uso dei biomarcatori per guidare le decisioni terapeutiche nel cancro gastrico/GEJ.
Il cancro gastrico è il quinto cancro più comune e la quarta causa principale di morte per tumore a livello mondiale. Negli Stati Uniti, il 62% dei casi di cancro gastrico/GEJ è avanzato alla diagnosi iniziale, con un tasso di sopravvivenza globale a cinque anni di solo il 6%.
Roche ha recibido la aprobación de la FDA para el VENTANA CLDN18 (43-14A) RxDx Assay, el primer diagnóstico companion para identificar a los pacientes con cáncer gástrico y cáncer de la unión gastroesofágica (GEJ) elegibles para un tratamiento dirigido con VYLOY. Este ensayo de inmunohistoquímica (IHC) ayuda a determinar la expresión de la proteína CLDN18 en tumores, permitiendo a los clínicos identificar a los pacientes que pueden beneficiarse de la terapia dirigida VYLOY (zolbetuximab).
El ensayo aborda una necesidad médica insatisfecha al ayudar a predecir la probabilidad de respuesta a la terapia dirigida en los cánceres gástricos y GEJ. CLDN18.2 es un biomarcador emergente en estos cánceres. Esta aprobación se alinea con las guías actuales que recomiendan el uso de biomarcadores para guiar la toma de decisiones terapéuticas en el cáncer gástrico/GEJ.
El cáncer gástrico es el quinto cáncer más común y la cuarta causa principal de muerte por cáncer en todo el mundo. En EE. UU., el 62% de los casos de cáncer gástrico/GEJ están avanzados en el diagnóstico inicial, con una tasa de supervivencia global a cinco años de solo el 6%.
로슈는 VENTANA CLDN18 (43-14A) RxDx Assay에 대해 FDA 승인을 받았습니다. 이는 VYLOY와 함께 표적 치료를 받을 수 있는 위암 및 위식도 접합부 (GEJ) 암환자를 식별하기 위한 첫 번째 동반 진단입니다. 이 면역조직화학(IHC) 검사는 종양 내 CLDN18 단백질 발현을 결정하는 데 도움을 주어, 의사가 아스텔라스의 표적 요법인 VYLOY(졸베투키스템)의 혜택을 받을 수 있는 환자를 식별할 수 있도록 합니다.
이 검사는 위암 및 GEJ 암에서 표적 치료에 대한 반응 가능성을 예측하여 의료 필요를 충족 시킵니다. CLDN18.2는 이러한 암에서 떠오르는 바이오마커입니다. 이 승인은 위암/GEJ 암의 치료 결정 과정에서 바이오 마커 사용을 권장하는 현재의 지침과 일치합니다.
위암은 세계에서 다섯 번째로 흔한 암이며, 암으로 인한 사망 원인 중 네 번째로 많은 비율을 차지합니다. 미국에서는 위암/GEJ 암 환자의 62%가 초기 진단 시 진행된 상태에 있으며, 5년 전체 생존율은 겨우 6%입니다.
Roche a reçu l'approbation de la FDA pour le VENTANA CLDN18 (43-14A) RxDx Assay, le premier test de diagnostic d'accompagnement pour identifier les patients atteints de cancer gastrique et de cancer de la jonction gastro-oesophagienne (GEJ) éligibles à un traitement ciblé avec VYLOY. Ce test d'immunohistochimie (IHC) aide à déterminer l'expression de la protéine CLDN18 dans les tumeurs, permettant aux cliniciens d'identifier les patients qui pourraient bénéficier de la thérapie ciblée VYLOY (zolbetuximab).
Le test répond à un besoin médical non satisfait en aidant à prédire la probabilité de réponse à la thérapie ciblée dans les cancers gastriques et GEJ. CLDN18.2 est un biomarqueur émergent dans ces cancers. Cette approbation est conforme aux directives actuelles recommandant l'utilisation de biomarqueurs pour orienter les décisions thérapeutiques dans le cancer gastrique/GEJ.
Le cancer gastrique est le cinquième cancer le plus courant et la quatrième cause de décès par cancer dans le monde. Aux États-Unis, 62 % des cas de cancer gastrique/GEJ sont avancés au moment du diagnostic initial, avec un taux de survie global de seulement 6 % sur cinq ans.
Roche hat die FDA-Zulassung für den VENTANA CLDN18 (43-14A) RxDx Assay erhalten, den ersten Begleitdiagnosetest zur Identifizierung von Patienten mit Magen- und gastroösophagealem Übergang (GEJ) Krebs, die für eine zielgerichtete Behandlung mit VYLOY in Frage kommen. Dieser immunhistochemische (IHC) Test hilft dabei, die CLDN18-Expression in Tumoren zu bestimmen, sodass Ärzte Patienten identifizieren können, die von der zielgerichteten Therapie VYLOY (Zolbetuximab) profitieren könnten.
Der Test adressiert ein unbefriedigtes medizinisches Bedürfnis, indem er die Wahrscheinlichkeit einer Reaktion auf die zielgerichtete Therapie bei Magen- und GEJ-Krebs vorhersagt. CLDN18.2 ist ein aufkommender Biomarker bei diesen Krebserkrankungen. Diese Genehmigung steht im Einklang mit den aktuellen Leitlinien, die die Verwendung von Biomarkern zur Unterstützung von Therapieentscheidungen bei Magen-/GEJ-Krebs empfehlen.
Magenkrebs ist die fünfhäufigste Krebsart und die vierthäufigste Todesursache durch Krebs weltweit. In den USA sind 62% der Fälle von Magen-/GEJ-Krebs bei der Erstdiagnose fortgeschritten, mit einer Gesamtüberlebensrate von nur 6% über fünf Jahre.
- FDA approval of VENTANA CLDN18 (43-14A) RxDx Assay as the first companion diagnostic for gastric and GEJ cancer
- Enables identification of patients eligible for targeted treatment with VYLOY
- Addresses unmet medical need in gastric and GEJ cancer treatment
- Aligns with current guidelines for biomarker use in therapeutic decision-making
- None.
Insights
The FDA approval of Roche's VENTANA CLDN18 (43-14A) RxDx Assay marks a significant advancement in personalized medicine for gastric and gastroesophageal junction (GEJ) cancer patients. This companion diagnostic test identifies patients with CLDN18.2-positive tumors, who may benefit from targeted therapy with VYLOY (zolbetuximab).
Key points to consider:
- This is the first FDA-approved IHC companion diagnostic for CLDN18 protein expression in gastric/GEJ cancers.
- CLDN18.2 is an emerging biomarker that can predict response to targeted therapy.
- The assay addresses an unmet medical need in a cancer type with poor prognosis (
6% 5-year survival rate for advanced cases). - It aligns with current guidelines recommending biomarker-guided treatment decisions.
For investors, this approval strengthens Roche's position in the companion diagnostics market and supports its personalized healthcare strategy. It also opens up a new revenue stream in the gastric/GEJ cancer diagnostic space, potentially driving growth in Roche's diagnostics division.
The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is a pivotal development in gastric and GEJ cancer treatment. Here's why it's significant:
- Gastric cancer is the 4th leading cause of cancer deaths worldwide, with treatment options for advanced cases.
62% of gastric/GEJ cancers in the U.S. are diagnosed at an advanced stage, underscoring the need for effective therapies.- VYLOY, the companion drug, is the first FDA-approved treatment specifically targeting CLDN18.2-positive, HER2-negative advanced gastric/GEJ cancers.
- This diagnostic-treatment combination exemplifies the shift towards precision oncology.
The assay's ability to identify CLDN18.2-positive tumors could significantly impact treatment decisions and potentially improve outcomes for a subset of patients. It's a step forward in addressing the challenges of late-stage diagnosis and poor survival rates in gastric/GEJ cancers.
- The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option.
- CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy.
- As the leader in companion diagnostics, Roche continues to build on its commitment to improve personalised healthcare to enable better patient outcomes.
"Patients who are diagnosed with gastric or gastroesophageal junction cancer are often diagnosed in an advanced stage as early symptoms can be similar across several conditions," said Jill German, Head of Pathology Lab at Roche Diagnostics. "Our companion diagnostic for CLDN18 can help identify patients eligible for targeted treatment and provide them with additional therapeutic options. With the launch of this test, Roche continues to advance personalised healthcare by expanding our innovative companion diagnostic portfolio."
Current guidelines for gastric/GEJ cancer recommend using biomarkers to guide therapeutic decision making. The new VENTANA CLDN18 (43-14A) RxDx Assay can help determine CLDN18.2 status and inform clinicians about the likelihood of patients benefiting from CLDN18.2 targeted therapy. VYLOY is the first FDA-approved treatment specifically targeting HER2-negative locally advanced unresectable or metastatic gastric or GEJ cancer patients whose tumours are CLDN18.2-positive.
Gastric cancer is the fifth most common cancer and the fourth leading cause of cancer deaths worldwide.1 In the
About the VENTANA CLDN18 (43-14A) RxDx Assay
The VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of Claudin 18 (CLDN18) protein in gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument. The assay is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with VYLOY® (zolbetuximab) in accordance with the approved therapeutic product labelling. The Roche test measures expression of both variants of the CLDN18 protein (18.1 and 18.2 isoforms). CLDN18.2 is the predominant variant expressed in gastric and GEJ cancers.5,6
The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is based on the results of the SPOTLIGHT and GLOW clinical studies where it was used as the enrollment assay to identify patients whose tumours were CLDN18.2 positive. CLDN18.2 positivity is defined as ≥
About Roche
Founded in 1896 in
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Sung H et al. CA Cancer J Clin 2021;71:209-49.
[2] ACS. Cancer Facts & Figures 2022. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf. Accessed 01-12-2022.
[3] NCI SEER Cancer stat facts: stomach cancer. https://seer.cancer.gov/statfacts/html/stomach.html. Accessed 11-30-2023.
[4] National Cancer Institute. Gastric Cancer Treatment (PDQ®)-Patient Version. Accessed at https://www.cancer.gov/types/stomach/patient/stomach-treatment-pdq on March 8, 2023.
[5] Saito, T. Matsuda, D. Moran, P-114 Claudin 18 isoform expression in gastric adenocarcinoma and pancreatic adenocarcinoma, Annals of Oncology, Volume 32, Supplement 3, 2021, Page S138, ISSN 0923-7534, https://doi.org/10.1016/j.annonc.2021.05.169.
[6]VENTANA® CLDN18 (43-14A) RxDx Assay Package Insert, 2023
[7] Astellas press release, Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium. https://www.astellas.com/en/news/26946. Accessed June 12, 2023.
[8] Astellas press release, Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series. https://www.astellas.com/en/news/27481. Accessed June 12, 2023.
Roche Media Relations
Jo Lynn Garing, 317-363-7286
jo_lynn.garing@roche.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-the-first-companion-diagnostic-to-identify-patients-with-gastric-and-gastroesophageal-junction-cancer-eligible-for-targeted-treatment-with-vyloy-302280715.html
SOURCE Roche
FAQ
What is the purpose of Roche's newly FDA-approved VENTANA CLDN18 (43-14A) RxDx Assay for RHHBY?
How does the VENTANA CLDN18 (43-14A) RxDx Assay work for RHHBY's gastric cancer diagnostics?
What is the significance of CLDN18.2 in gastric and GEJ cancers for RHHBY's new diagnostic?
What are the current statistics on gastric cancer diagnosis and survival rates relevant to RHHBY's new assay?
