Beijing, March 15th (Reporter Cao Qian, Intern Xie Xiaoxuan) Today, BeiGene announced that its PD-1 inhibitor, Tevimbra, has been approved by the FDA for the treatment of advanced or metastatic esophageal squamous cell carcinoma (ESCC) that has progressed after chemotherapy.
CCTV Capital has noticed that after Junshi Biotech's Treprizumab was approved by the FDA as the first nasopharyngeal cancer treatment drug, BeiGene's Treprizumab has become the second domestically produced PD-1 successfully exported to the United States.
The FDA's approval this time is based on clinical data from RATIONALE 302, with chemotherapy as a control and mOS of 8.6 months and 6.3 months, respectively, reducing the risk of death by 30%.
Baekje Shenzhou stated that the trial aims to evaluate the effectiveness and safety of chemotherapy chosen by Baekje's comparative researchers for second-line treatment of advanced or metastatic ESCC patients.
According to public reports, the FDA is still reviewing the BLA of tirizizumab as a first-line therapy for unresectable, recurrent, locally advanced or metastatic ESCC patients, as well as locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients. The Prescription Drug User Payment Act (PDUFA) dates are July and December of this year, respectively.
According to data from the World Health Organization, approximately 550000 people worldwide died from esophageal squamous cell carcinoma in 2020, with approximately 600000 new cases. Some viewpoints point out that the approval of tirizizumab provides new therapeutic hope for these patients. (CCTV Capital Eye)