China-based biotech firm BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has been granted market approval in Israel for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The Israeli Ministry of Health has approved Tevimbra for use as a monotherapy second-line treatment for adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC), following chemotherapy. This approval comes on the heels of the European Medicines Agency’s approval for the same indication in 2023.
BeiGene has an extensive clinical development program for Tevimbra, with 17 registration-enabling trials initiated, including 11 Phase III and 4 Phase II studies that have reported positive results. In Israel, the company has also submitted applications for first- and second-line treatments for squamous and non-squamous non-small cell lung cancer (NSCLC), with additional filings for first-line ESCC and gastric cancer on the horizon. – Flcube.com
