AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) has been accepted by the FDA for Priority Review. This application, based on the positive ADRIATIC Phase III trial results in patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after platinum-based concurrent chemoradiotherapy, aims to offer significant improvements in treatment.
The FDA’s Priority Review designation is given to drugs that promise major advances in treatment. The Prescription Drug User Fee Act (PDUFA) date for the FDA’s decision is expected in the fourth quarter of 2024. Additionally, IMFINZI has received Breakthrough Therapy Designation (BTD), expediting its development for addressing serious conditions with unmet needs.
SCLC is a rapidly progressing lung cancer with a poor prognosis; only 15-30% of LS-SCLC patients survive five years post-diagnosis. Data from the ADRIATIC trial, presented at the 2024 ASCO Annual Meeting, showed IMFINZI reduced the risk of death by 27% and progression or death by 24% compared to placebo. IMFINZI’s safety profile remains consistent with known data, with no new safety concerns identified.
Susan Galbraith, EVP of Oncology R&D at AstraZeneca, emphasized the potential of IMFINZI to significantly improve outcomes for LS-SCLC patients and expressed eagerness to collaborate with the FDA for swift patient access.
IMPORTANT SAFETY INFORMATION: There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).
