The FDA approved BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) as a second-line esophageal cancer treatment Thursday, marking its first US clearance after a series of setbacks.
The approval was based on data from the Phase III RATIONALE 302 study, which enrolled 512 patients from Europe, the US and Asia. Data showed that the anti-PD-1 monoclonal antibody (mAb) demonstrated a 30% reduction in the risk of death and extended median overall survival by 2.3 months compared to chemotherapy.
Path to approval
Tevimbra’s FDA approval comes more than a year and a half later than originally expected.
The agency’s review, originally slated for July 2022, was deferred after it was unable to conduct required inspections in China due to COVID-19 related travel restrictions.
And last September, BeiGene regained global rights to Tevimbra after partner Novartis ended a licensing deal. The Swiss drugmaker had paid $650 million upfront in 2021 for rights to the mAb in several major markets outside China. However, the deal termination came the same day European regulators approved the drug to treat ESCC.
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