AstraZeneca says EC grants marketing authorization for Imfinzi

AstraZeneca  and MedImmune announced that the European Commission has granted marketing authorisation for Imfinzi as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer in adults whose tumours express PD-L1 on greater than or equal to1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy. The approval is based on results from the Phase III PACIFIC trial. The approval follows the positive opinion on 27 July 2018 from the CHMP of the European Medicines Agency. The most common adverse reactions of Imfinzi versus placebo were cough, upper respiratory tract infections and rash. 12.8% of patients experienced a grade 3 or 4 AE with Imfinzi vs 9.8% with placebo. Imfinzi is approved for the treatment of patients with unresectable, Stage III NSCLC in the US, Canada, Switzerland, India, Japan and Brazil. Other global health authority reviews and submissions are ongoing.

https://thefly.com/landingPageNews.php?id=2794561