On March 15th, Baekje announced that the US Food and Drug Administration (FDA) has approved tirizumab as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy (excluding PD-1/L1 inhibitors). Tirelizumab is expected to be launched in the United States in the second half of 2024.
This approval marks the first indication for tirizumab in the United States, and the drug has also become the second PD-1 monoclonal antibody approved for market by the FDA in China.
Prior to this, in September 2023, BeiGene announced that Tirelizumab had been approved by the European Commission for the treatment of adult patients with unresectable, locally advanced, or metastatic ESCC after previous platinum containing chemotherapy, becoming the first successful Chinese PD-1 monoclonal antibody to go abroad. In February 2024, tirizizumab received positive feedback from the European Medicines Agency's Human Medicines Committee, recommending approval for its use in the treatment of three indications for non-small cell lung cancer.
It is reported that the FDA is currently reviewing the application for market authorization (BLA) of new drugs using tirelizumab for first-line treatment of unresectable, recurrent, locally advanced or metastatic ESCC patients, as well as for the treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma patients. It is expected that the FDA will make decisions on these two BLAs in July and December 2024, respectively.
BeiGene has conducted over 17 potential registered clinical trials of tirelizumab, with 11 phase 3 randomized trials and 4 phase 2 trials yielding positive results. As of now, over 900000 patients worldwide have received treatment with tirizizumab.