AstraZeneca’s Imfinzi approved in U.S. as immunotherapy regimen for LS-SCLC

AstraZeneca’s (AZN) Imfinzi has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer, LS-SCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted by the Food and Drug Administration, FDA, after securing Priority Review and Breakthrough Therapy Designation. It was based on results from the ADRIATIC Phase III trial which were presented during the Plenary Session of the 2024 American Society of Clinical Oncology, ASCO, Annual Meeting and subsequently published in the New England Journal of Medicine. In the trial, Imfinzi reduced the risk of death by 27% versus placebo and also reduced the risk of disease progression or death by 24%.