BeOne Medicines (ONC) said Wednesday that the European Commission has approved Tevimbra, in combination with platinum-based chemotherapy as a neoadjuvant treatment, followed by Tevimbra alone after surgery, for adults with resectable non-small cell lung cancer at high risk of recurrence.
The company said the approval is based on the final analysis of Phase 3 trial data, which showed that the Tevimbra regimen significantly improved overall survival compared to chemotherapy plus placebo.
With a median follow-up of 38.5 months, the study also confirmed sustained benefits in event-free survival, major pathological response, and pathological complete response across various patient subgroups-regardless of PD-L1 levels, disease stage, or tumor type, the company said.
Tevimbra is already approved in the EU for four indications related to lung cancer and other cancer treatments.
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