BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a multinational oncology company planning to change its name to BeOne Medicines Ltd, announced that it has received another indication approval from the US Food and Drug Administration (FDA) for its Tevimbra (tislelizumab). The PD – 1 inhibitor is now approved for use in combination with platinum for first – line unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD – L1 (≥1).
FDA Approval Based on Clinical Trial Results
The FDA approval is based on positive results from the global Phase III RATIONALE – 306 study. The study demonstrated a significant improvement in overall survival (OS: 16.8 months vs 9.6 months, HR = 0.66) in patients with first – line PD – L1 positive ESCC when treated with tislelizumab combined with platinum. Additionally, the combination therapy showed a good overall safety profile.
Tislelizumab’s Previous Approvals
Tislelizumab, registered in 45 markets worldwide, was first approved in the US in March of last year for the treatment of unresectable or metastatic ESCC patients previously treated with systemic chemotherapy without prior PD – (L)1 inhibitor treatment. It also received approval in December of the same year for the treatment of first – line unresectable or metastatic HER2 – negative gastric or gastroesophageal junction adenocarcinoma (G / GEJ) in adults whose tumors express PD – L1 (≥1).-Fineline Info & Tech
Leave a Reply