UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that the US Food and Drug Administration (FDA) has accepted for review an additional indication filing for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The filing, which seeks approval for the treatment of muscle-invasive bladder cancer (MIBC), has also been granted priority review status, with the Prescription Drug User Fee Act (PDUFA) date anticipated during the second quarter of 2025.
Phase III NIAGARA Study Supports the Filing
The filing is supported by the results of the Phase III NIAGARA study, an interim analysis of which demonstrated that Imfinzi combined with chemotherapy led to statistically and clinically meaningful improvements in the primary endpoint of event-free survival (EFS) and the secondary key indication of overall survival (OS) compared to chemotherapy alone. The combination therapy reduced the risk of recurrence by 32% and the risk of death by 25% compared to chemotherapy alone.
Implications for Muscle-Invasive Bladder Cancer Treatment
The acceptance of the filing and the priority review status underscore the potential impact of Imfinzi on the treatment landscape for muscle-invasive bladder cancer. If approved, Imfinzi could offer a new therapeutic option for patients with MIBC, building on its existing approvals in other cancer indications.-Fineline Info & Tech
