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 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.
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