BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®
“We are excited to announce the European Commission approval and the FDA filing acceptance for tislelizumab, having recently regained full global rights to this important medicine.
- “We are excited to announce the European Commission approval and the FDA filing acceptance for tislelizumab, having recently regained full global rights to this important medicine.
- The study enrolled 513 patients from 132 research sites in 11 countries in Europe, Asia and North America.
- The FDA has assigned a target action date in the second half of 2024, under the Prescription Drug User Fee Act.
- The FDA also granted tislelizumab Orphan Drug Designation (ODD) for the treatment of previously untreated advanced or metastatic ESCC.