BeiGene has received approval from the Israeli Ministry of Health for Tevimbra (tislelizumab) as a treatment for adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC) who have previously undergone systemic chemotherapy.
This approval makes Tevimbra available as a monotherapy for those affected by the disease.
Tislelizumab is a humanised immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody. It has been designed to target PD-1 with high specificity while avoiding binding to Fc-gamma receptors on macrophages, a feature that helps the immune system identify and respond to tumours.
BeiGene said that it is focusing on expanding Tevimbra’s availability in Israel. The company has submitted applications for its use as a first- and second-line treatment for both squamous and non-squamous non-small cell lung cancer (NSCLC).
The oncology company also plans to file for additional approvals, including for first-line oesophageal squamous cell carcinoma (OESCC) and gastric cancer.
BeiGene Israel country general manager Itzik Mizrahi said: “In Israel, the incidence of cancer continues to rise, with solid tumours 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 oesophageal squamous cell carcinoma (ESCC), offering renewed hope and potentially improved outcomes for those affected by these challenging malignancies.
“We are pleased to have received approval in Israel, which represents a significant step forward in our mission to bring innovative treatments to cancer patients around the world.”
BeiGene has conducted over 17 trials with Tevimbra, 11 of which are Phase 3 randomised trials and four Phase 2 trials, many of which have produced positive outcomes. These trials have demonstrated the drug’s potential to improve survival rates and quality of life for cancer patients across multiple tumour types, including cases that do not depend on PD-(L)1 status.
To date, more than 900,000 patients worldwide have been treated with Tevimbra.
Tislelizumab has also received European Commission approval in 2023 for the treatment of advanced or metastatic oesophageal squamous cell carcinoma following prior chemotherapy. Additionally, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on tislelizumab in February 2024 for its use in non-small cell lung cancer across three indications.
