AstraZeneca: CHMP green lights Imfinzi in EU

(CercleFinance.com) - AstraZeneca announces that Imfinzi (durvalumab) has been recommended for approval in the European Union as monotherapy for adult patients with limited small-cell lung cancer (LS-SCLC) who have not progressed after platinum-based chemoradiotherapy.


This recommendation by the CHMP (Committee for Medicinal Products for Human Use) of the EMA (European Medicines Agency) is based on the results of a Phase III trial published in The New England Journal of Medicine, which showed a 27% reduction in the risk of death compared with placebo.

Median overall survival was 55.9 months with Imfinzi versus 33.4 months with placebo. The drug also reduced the risk of progression or death by 24%.

Imfinzi is already approved in the US and several other countries, and applications are under review in Japan and elsewhere.


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