BeOne Medicines (ONC) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Tevimbra for treating adults with resectable non-small cell lung cancer at high risk of recurrence.
The recommendation covers Tevimbra for use with chemotherapy as neoadjuvant treatment and continued as monotherapy as adjuvant treatment.
The drugmaker said the recommendation was based on a phase 3 trial, where the treatment met key goals of event-free survival and major pathologic response at the interim analyses.
Shares of the company were up 2.6% in Monday's premarket activity.
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