AstraZeneca: IMFINZI gets priority review and BTD to treat LS-SCLC patients

AstraZeneca’s supplemental Biologics License Application sBLA for IMFINZI durvalumab , based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer LS-SCLC whose disease has not progressed following platinum-based concurrent chemoradiotherapy cCRT , has been accepted and granted Priority Review in the US. The Food and Drug Administration FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024. IMFINZI was also recently granted Breakthrough Therapy Designation BTD by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.