Posted by Michael Wonder on 29 Jul 2025
BeOne Medicines receives positive CHMP opinion for Tevimbra in neo-adjuvant/adjuvant NSCLC treatment
28 July 2025 - Recommendation based on Phase 3 RATIONALE-315 study, in which Tevimbra demonstrated clinically meaningful and statistically significant improvement in event-free survival and major pathological response.
BeOne Medicines today announced that the CHMP of the EMA issued a positive opinion recommending approval of Tevimbra (tislelizumab), in combination with platinum-containing chemotherapy as neo-adjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer at high risk of recurrence.
