EC approves BeiGene's tislelizumab for three NSCLC indications in EU

BeOne Medicines Ltd.

EC approved tislelizumab on April 23, 2024 for first-line squamous NSCLC, first-line non-squamous PD-L1≥50%, and second-line after prior platinum therapy.
Approval based on three Phase 3 RATIONALE trials (307, 304, 303) enrolling 1,499 patients, showing PFS and OS benefits.
This is tislelizumab's second EU approval; previously approved for ESCC; brand will unify under TEVIMBRA later in 2024.
BeiGene plans to launch in first EU countries in 2024; over 900,000 patients prescribed tislelizumab globally.

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