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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