BeiGene's Tevimbra Approved in Israel for Advanced Esophageal Cancer
Key Insights
The Israeli Ministry of Health has approved Tevimbra (tislelizumab) as a monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (OSCC (search)).
This approval provides a new treatment option for adult patients who have previously undergone systemic chemotherapy, addressing a critical need in cancer care.
BeiGene (search) is expanding Tevimbra's availability in Israel, with submissions for first- and second-line treatments for non-small cell lung cancer (search) (NSCLC (search)) underway.
The Israeli Ministry of Health has approved BeiGene (search)'s Tevimbra (tislelizumab) as a monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (search) (OSCC (search)) who have previously undergone systemic chemotherapy. This approval marks a significant step forward in providing innovative cancer treatments to patients in Israel.
BeiGene (search) is focusing on increasing the accessibility of Tevimbra in Israel, with recent submissions for regulatory approval for first- and second-line treatments for squamous and non-squamous non-small cell lung cancer (search) (NSCLC (search)). Further filings are anticipated for first-line OSCC (search) and gastric cancer (search).
Itzik Mizrahi, Country General Manager of BeiGene (search) Israel, stated, "In Israel, the incidence of cancer continues to rise, with solid tumors 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 esophageal squamous cell carcinoma (ESCC (search)), offering renewed hope and potentially improved outcomes for those affected by these challenging malignancies."
Clinical Evidence and Global Impact
Tevimbra has demonstrated its potential to improve survival and quality of life for cancer patients across various tumor types, both as a monotherapy and in combination with other treatments. BeiGene (search) has initiated 17 trials that could lead to registration for Tevimbra, with 11 Phase III and four Phase II trials already showing positive outcomes. More than 900,000 patients worldwide have been treated with Tevimbra.
In 2023, the European Commission granted approval for Tevimbra to treat advanced or metastatic ESCC (search) 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 (search) across three indications.
About Tislelizumab
Tislelizumab is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1 (search)) monoclonal antibody. It is engineered for high affinity and specificity to PD-1 and to minimize Fcγ receptor binding on macrophages. This design enhances the immune system's ability to detect and combat tumors.
BeiGene's Commitment
BeiGene (search) is committed to developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, the company is expediting the development of its diverse pipeline of novel therapeutics through internal capabilities and collaborations.