TEVIMBRA by BeiGene approved for OSCC in Israel

The Israeli Ministry of Health (IL MOH) has recently approved BeiGene’s TEVIMBRA (tislelizumab) as a treatment for adults with unresectable or metastatic oesophageal squamous cell carcinoma (OSCC) who have previously undergone systemic chemotherapy. This development marks a significant milestone in cancer treatment accessibility in Israel, aligning with BeiGene's broader strategy to expand the availability of TEVIMBRA.

TEVIMBRA, a humanised immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody, has been designed with high affinity and specificity to PD-1, which minimizes Fcγ receptor binding on macrophages. This engineering is intended to enhance the immune system's capability to detect and combat tumours effectively. The drug has demonstrated potential not only as monotherapy but also in combination with other treatments, significantly improving the survival rates and quality of life for cancer patients.

BeiGene is proactively working to ensure that TEVIMBRA reaches more patients in Israel. The company has submitted recent applications for regulatory approval in treating first and second-line squamous and non-squamous non-small cell lung cancer. Further submissions are anticipated for first-line OSCC and gastric cancer shortly.

Globally, TEVIMBRA has been a part of 17 clinical trials aiming for registration, including 11 Phase III and four Phase II trials that have already shown promising results. The drug has been pivotal in treating nearly 900,000 cancer patients worldwide. Its efficacy and safety profiles have been well-documented, leading to significant approvals in various regions.

In 2023, the European Commission granted approval for TEVIMBRA to treat advanced or metastatic oesophageal squamous cell carcinoma following prior chemotherapy. Additionally, in February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) provided a positive opinion for TEVIMBRA to be used in treating non-small cell lung cancer across three indications.

Itzik Mizrahi, BeiGene Israel's country general manager, expressed optimism about the approval, emphasizing that the incidence of cancer continues to rise in Israel, with solid tumours posing a significant health challenge. According to Mizrahi, the recent approval of TEVIMBRA by the Israeli Ministry of Health offers a new, innovative treatment for patients with OSCC, providing renewed hope and potentially better outcomes for those affected by this challenging malignancy. He noted that the approval represents a major step forward in BeiGene's mission to bring innovative treatments to cancer patients globally.

The commitment to expanding TEVIMBRA’s reach is evident in BeiGene's strategy and ongoing efforts to file for additional regulatory approvals. The positive outcomes from the clinical trials and subsequent regulatory green lights highlight the drug's potential in addressing unmet medical needs in the oncology space. The company's forward-thinking approach and dedication to improving cancer treatment options serve as a beacon of hope for patients and healthcare providers alike.