On September 17, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported that the Israeli Ministry of Health (IL MOH) has approved TEVIMBRA (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC) after prior systemic chemotherapy (Press release, BeiGene, SEP 17, 2024, View Source [SID1234646697]).
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"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 Israel, which represents a significant step forward in our mission to bring innovative treatments to cancer patients around the world."
BeiGene is focused on expanding the availability of Tevimbra in Israel. The company has recently submitted applications for first- and second-line treatments for both squamous and non-squamous non-small cell lung cancer (NSCLC) and plans future filings for first-line oesophageal squamous cell carcinoma (OESCC) and gastric cancer (GC).
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.