BeiGene Scores Two Major FDA Approvals – Trivimbra for Esophageal Cancer and Brukinsa for Follicular Lymphoma
1. BeiGene receives FDA approval for their PD-1 inhibitor, Trivimbra (tislelizumab), to treat advanced esophageal squamous cell carcinoma after previous systemic chemotherapy.
- Trivimbra joins existing PD-1 drugs like Keytruda and Opdivo already approved for esophageal cancer.
- The product was initially delayed due to COVID-19 related travel restrictions preventing preapproval inspections.
2. The FDA grants accelerated approval to zanubrutinib (marketed as Brukinsa) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
- Brukinsa has been approved in 50 markets and supports a broad clinical program.