BeiGene receives EC approval for TEVIMBRA in ESCC; FDA accepts BLA for first-line ESCC

BeOne Medicines Ltd.

EC approved TEVIMBRA (tislelizumab) as monotherapy for adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.
FDA accepted BLA for tislelizumab as first-line treatment for unresectable, recurrent, locally advanced, or metastatic ESCC; target action date H2 2024.
Approval based on RATIONALE 302 trial: median OS 8.6 vs 6.3 months (HR 0.70; p=0.0001) for TEVIMBRA vs chemotherapy.
FDA also granted Orphan Drug Designation for tislelizumab in previously untreated advanced or metastatic ESCC.
BeiGene recently regained full global rights to TEVIMBRA; more than 750,000 patients prescribed to date.

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