TEVIMBRA monotherapy is indicated for treating unresectable or metastatic oesophageal squamous cell carcinoma. Credit: SewCreamStudio/Shutterstock.

The Israeli Ministry of Health (IL MOH) has approved BeiGene’s TEVIMBRA (tislelizumab) as a monotherapy to treat adults with unresectable or metastatic oesophageal squamous cell carcinoma (OSCC) who have previously undergone systemic chemotherapy.

The company is focusing on increasing TEVIMBRA’s accessibility in Israel, with recent submissions for regulatory approval in treating first and second-line squamous and non-squamous non-small cell lung cancer.

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Further filings by the company are anticipated for first-line OSCC and gastric cancer soon.

A humanised immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody, tislelizumab is engineered for high affinity and specificity to PD-1 and to minimise Fcγ receptor binding on macrophages.

This design enhances the immune system’s ability to detect and combat tumours.

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BeiGene has initiated 17 trials that could lead to registration for TEVIMBRA, with 11 Phase III and four Phase II trials already showing positive outcomes.

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TEVIMBRA has shown potential to improve survival and quality of life for cancer patients across various tumour types, as both monotherapy and in combination with other treatments.

900,000 patients across the globe have been treated with TEVIMBRA.

In 2023, the European Commission granted approval for TEVIMBRA to treat advanced or metastatic ESCC following prior chemotherapy.

In February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) gave a positive opinion for its use in non-small cell lung cancer across three indications.

BeiGene Israel country general manager Itzik Mizrahi stated: “In Israel, the incidence of cancer continues to rise, with solid tumours representing a substantial health burden, and access to these inhibitors remains limited for patients. The recent approval of Tevimbra by the Israeli Ministry of Health provides a new, innovative treatment for patients with oesophageal squamous cell carcinoma, 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.”

In August 2024, the US Food and Drug Administration granted fast-track designation for BeiGene’s BGB-16673 to treat adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma.