AstraZeneca's Imfinzi Granted US Priority Review and Breakthrough Therapy Designation for Limited-Stage Small Cell Lung Cancer

AstraZeneca announced on August 15, 2024, that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted for Priority Review by the US Food and Drug Administration (FDA). The application is for patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent chemoradiotherapy (cCRT). Imfinzi also received Breakthrough Therapy Designation (BTD) from the FDA in this setting.

Priority Review is granted to applications for medicines that are intended to offer significant improvements over available therapies. The FDA's target action date for regulatory decision is anticipated in the fourth quarter of 2024. Breakthrough Therapy Designation is designed to accelerate the development and review of potential new medicines for serious conditions that address significant unmet medical needs.

Small cell lung cancer is an aggressive disease with a poor prognosis, particularly for LS-SCLC patients. The positive results from the ADRIATIC Phase III trial formed the basis of the application. The trial demonstrated that Imfinzi significantly improved both overall survival (OS) and progression-free survival (PFS) compared to placebo. Specifically, Imfinzi reduced the risk of death by 27% and the risk of disease progression or death by 24%.

"This Priority Review reinforces the potential of Imfinzi to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival benefit in limited-stage small cell lung cancer," said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. "There is an urgent need for new treatment options that improve upon the standard of care in this setting, which has not changed in forty years."