BeiGene Receives Israeli Ministry of Health Approval for TEVIMBRA® for the Treatment of Oesophageal Squamous Cell Carcinoma (OSCC) After Prior Chemotherapy
BeiGene (NASDAQ: BGNE) has announced that the Israeli Ministry of Health has approved TEVIMBRA® (tislelizumab) for treating adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC) after prior systemic chemotherapy. This approval marks a significant step in BeiGene's mission to provide innovative cancer treatments globally.
BeiGene is expanding TEVIMBRA's availability in Israel, with recent submissions for first- and second-line treatments for non-small cell lung cancer (NSCLC) and planned filings for first-line OESCC and gastric cancer. The company has conducted over 17 potentially registration-enabling trials with TEVIMBRA, demonstrating its potential to improve survival benefits across various tumor types.
Globally, more than 900,000 patients have been prescribed TEVIMBRA. The drug received approval from the European Commission for advanced or metastatic ESCC in 2023 and a positive opinion from the EMA for NSCLC treatment in February 2024.
BeiGene (NASDAQ: BGNE) ha annunciato che il Ministero della Salute israeliano ha approvato TEVIMBRA® (tislelizumab) per il trattamento di pazienti adulti con carcinoma squamoso esofageo irresecabile o metastatico (OESCC) dopo una precedente chemioterapia sistemica. Questa approvazione rappresenta un passo significativo nella missione di BeiGene di fornire trattamenti innovativi contro il cancro a livello globale.
BeiGene sta ampliando la disponibilità di TEVIMBRA in Israele, con recenti presentazioni per trattamenti di prima e seconda linea per il cancro polmonare non a piccole cellule (NSCLC) e previsioni di presentazioni per il trattamento di prima linea dell'OESCC e del cancro gastrico. L'azienda ha condotto oltre 17 studi potenzialmente favorevoli alla registrazione con TEVIMBRA, dimostrando il suo potenziale di migliorare i benefici per la sopravvivenza in vari tipi di tumore.
A livello globale, più di 900.000 pazienti sono stati prescritti TEVIMBRA. Il farmaco ha ricevuto l'approvazione dalla Commissione Europea per l'ESCC avanzato o metastatico nel 2023 e un parere positivo dall'EMA per il trattamento del NSCLC nel febbraio 2024.
BeiGene (NASDAQ: BGNE) ha anunciado que el Ministerio de Salud de Israel ha aprobado TEVIMBRA® (tislelizumab) para el tratamiento de pacientes adultos con carcinoma de células escamosas esofágicas irresecable o metastásico (OESCC) después de una quimioterapia sistémica previa. Esta aprobación marca un avance significativo en la misión de BeiGene de ofrecer tratamientos innovadores contra el cáncer a nivel mundial.
BeiGene está ampliando la disponibilidad de TEVIMBRA en Israel, con presentaciones recientes para tratamientos de primera y segunda línea para el cáncer de pulmón no microcítico (NSCLC) y planes de presentar solicitudes para el tratamiento de primera línea del OESCC y cáncer gástrico. La compañía ha realizado más de 17 ensayos potencialmente habilitantes para registro con TEVIMBRA, demostrando su potencial para mejorar los beneficios de supervivencia en varios tipos de tumores.
A nivel mundial, más de 900,000 pacientes han sido tratados con TEVIMBRA. El fármaco recibió la aprobación de la Comisión Europea para el ESCC avanzado o metastásico en 2023 y un dictamen positivo de la EMA para el tratamiento del NSCLC en febrero de 2024.
BeiGene (NASDAQ: BGNE)는 이스라엘 보건부가 TEVIMBRA® (티슬리주맙)을 이전에 전신 화학요법을 받은 절제 불가능한 또는 전이성 식도 편평세포 암종(OESCC) 성인 환자를 치료하기 위해 승인했다고 발표했습니다. 이 승인은 BeiGene의 전 세계적으로 혁신적인 암 치료를 제공하려는 사명의 중요한 이정표입니다.
BeiGene은 최근 비소세포 폐암(NSCLC)을 위한 1차 및 2차 치료제에 대한 신청을 통해 이스라엘에서 TEVIMBRA의 가용성을 확대하고 있으며, OESCC 및 위암을 위한 1차 치료제에 대한 신청도 계획하고 있습니다. 이 회사는 TEVIMBRA로 등록 가능성 있는 17개 이상의 시험을 수행하여 다양한 종양 유형에서 생존 혜택을 개선할 수 있는 잠재력을 입증했습니다.
전 세계적으로, 90만 명 이상의 환자들이 TEVIMBRA를 처방받았습니다. 이 약물은 2023년에 고형 또는 전이성 ESCC에 대해 유럽 집행위원회의 승인을 받았고, 2024년 2월 NSCLC 치료에 대해 EMA의 긍정적인 의견을 받았습니다.
BeiGene (NASDAQ: BGNE) a annoncé que le ministère israélien de la Santé a approuvé TEVIMBRA® (tislelizumab) pour traiter des patients adultes atteints de carcinome épidermoïde œsophagien irrésecable ou métastatique (OESCC) après une chimiothérapie systémique préalable. Cette approbation constitue une étape significative dans la mission de BeiGene de fournir des traitements innovants contre le cancer à l'échelle mondiale.
BeiGene élargit la disponibilité de TEVIMBRA en Israël, avec des soumissions récentes pour des traitements de première et deuxième ligne pour le cancer du poumon non à petites cellules (NSCLC) et des dépôts prévus pour le traitement de première ligne de l'OESCC et du cancer gastrique. L'entreprise a réalisé plus de 17 essais potentiellement susceptibles de permettre l'enregistrement avec TEVIMBRA, démontrant son potentiel à améliorer les bénéfices de survie dans divers types de tumeurs.
Au niveau mondial, plus de 900 000 patients ont été prescrits avec TEVIMBRA. Le médicament a obtenu l'approbation de la Commission européenne pour l'ESCC avancé ou métastatique en 2023 et un avis positif de l'EMA pour le traitement du NSCLC en février 2024.
BeiGene (NASDAQ: BGNE) hat bekannt gegeben, dass das israelische Gesundheitsministerium TEVIMBRA® (Tislelizumab) zur Behandlung von erwachsenen Patienten mit irresezierbarem oder metastasiertem Plattenepithelkarzinom der Speiseröhre (OESCC) nach vorheriger systemischer Chemotherapie genehmigt hat. Diese Genehmigung stellt einen bedeutenden Schritt in BeiGenes Mission dar, innovative Krebsbehandlungen weltweit anzubieten.
BeiGene erweitert die Verfügbarkeit von TEVIMBRA in Israel und hat kürzlich Anträge für Erst- und Zweitlinienbehandlungen bei nicht-kleinzelligem Lungenkrebs (NSCLC) eingereicht und plant Anmeldungen für die Erstlinienbehandlung von OESCC und Magenkrebs. Das Unternehmen hat über 17 potenziell registrierungsfähige Studien mit TEVIMBRA durchgeführt, die das Potenzial zur Verbesserung der Überlebensvorteile bei verschiedenen Tumorarten demonstrieren.
Weltweit haben mehr als 900.000 Patienten TEVIMBRA verschrieben bekommen. Das Medikament erhielt 2023 von der Europäischen Kommission die Genehmigung für fortgeschrittenes oder metastasiertes ESCC und eine positive Stellungnahme von der EMA für die Behandlung von NSCLC im Februar 2024.
- Approval of TEVIMBRA® for OESCC treatment in Israel, expanding market reach
- Planned submissions for additional indications in Israel, potentially increasing future revenue streams
- Positive results from 11 Phase 3 and 4 Phase 2 trials, demonstrating TEVIMBRA's efficacy
- Over 900,000 patients prescribed TEVIMBRA globally, indicating strong market adoption
- Recent European approvals and positive opinions, suggesting potential for further market expansion
- None.
Insights
The approval of TEVIMBRA® (tislelizumab) by the Israeli Ministry of Health for unresectable or metastatic oesophageal squamous cell carcinoma (OESCC) is a significant development. This monotherapy treatment option for patients who have undergone prior systemic chemotherapy addresses a critical need in cancer care. The approval is based on robust clinical evidence, with 11 Phase 3 and four Phase 2 trials showing positive results.
What's particularly noteworthy is TEVIMBRA's potential efficacy regardless of PD-(L)1 status, which could broaden its applicability. With
BeiGene's strategic expansion in Israel marks a significant move in the global oncology market. The approval of TEVIMBRA® not only addresses an unmet medical need but also positions BeiGene as a key player in the Israeli cancer treatment landscape. With plans to file for additional indications, including first-line treatments for various cancers, BeiGene is poised for potential market growth.
The company's robust clinical trial program, with 17 potentially registration-enabling trials, demonstrates a strong pipeline and commitment to expanding TEVIMBRA's applications. This approach could lead to increased market share and revenue streams. The recent European approvals and positive opinions further validate TEVIMBRA's global potential, potentially influencing investor confidence in BeiGene's international expansion strategy.
The approval of TEVIMBRA® by the Israeli Ministry of Health signifies a shift in the country's approach to cancer treatment. By introducing an innovative therapy for OESCC, Israel is aligning with global trends in personalized medicine and targeted therapies. This move could potentially reduce the economic burden of cancer treatment on the healthcare system by offering more effective options.
However, it's important to consider the potential impact on healthcare budgets and access. The introduction of new, potentially costly treatments often requires careful health technology assessment and pricing negotiations. The success of TEVIMBRA in Israel will depend not only on its clinical efficacy but also on its cost-effectiveness and integration into existing treatment protocols. This approval may set a precedent for future innovative cancer therapies in the Israeli market.
HERZLIYA,
"In Israel, the incidence of cancer continues to rise, with solid tumors representing a substantial health burden and where access to these inhibitors remains limited for the patients. The recent approval of Tevimbra by the Israeli Ministry of Health provides a new, innovative treatment for patients with esophageal squamous cell carcinoma (ESCC), offering renewed hope and potentially improved outcomes for those affected by these challenging malignancies,” said Itzik Mizrahi, Country General Manager of BeiGene Israel. "We are pleased to have received approval in
BeiGene is focused on expanding the availability of Tevimbra in
BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts. Through these trials, TEVIMBRA has demonstrated its potential to deliver clinically meaningful improvements in survival benefits and quality of life for hundreds of thousands of cancer patients across a range of tumor types – in many cases, regardless of PD-(L)1 status – both as monotherapy and in combination with other regimens. More than 900,000 patients have been prescribed TEVIMBRA globally to date.
Tislelizumab received approval by the European Commission for advanced or metastatic ESCC after prior chemotherapy in 2023 and a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in February 2024 as a treatment for non-small cell lung cancer across three indications.
About TEVIMBRA® (tislelizumab)
Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
About BeiGene
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240917512210/en/
For more information:
Lou Carter
Lou.carter@Beigene.com
Rosa Soto
Rosa.soto@beigene.com
Source: BeiGene, Ltd.
FAQ
What is the new approval for TEVIMBRA® (tislelizumab) in Israel?
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