07:32 AM EDT, 03/31/2025 (MT Newswires) -- BeiGene ( ONC ) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Tevimbra combined with etoposide and platinum chemotherapy as a first-line treatment for extensive-stage small cell lung cancer.
The company said the recommendation is based on a phase 3 study that showed a median overall survival of 15.5 months in patients treated with Tevimbra plus chemotherapy compared with 13.5 months for placebo plus chemotherapy.
BeiGene ( ONC ) said Tevimbra with chemotherapy was also generally well tolerated, with no new safety signals observed.
Shares of the company were up more than 3% in recent premarket activity.