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BeOne Medicines' Tevimbra获得CHMP认可
2025-07-28 21:31
- The European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") has issued a positive opinion for BeOne Medicines' Tevimbra (tislelizumab) for use as an neoadjuvant therapy followed by adjuvant treatment for non-small cell lung cancer.
- The recommendation was based on data from the phase 3 RATIONALE-315 study that demonstrated statistically significant and clinically meaningful improvement in major pathological response, pathological complete response, and event-free survival.
- If approved, the new indication would have Tevimbra in combination with chemotherapy as a neoadjuvant therapy followed by monotherapy as adjuvant treatment.
- In the EU, Tevimbra is already approved for NSCLC and small-cell lung cancer in first- and second-line settings.
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