Muscle Invasive Urothelial Carcinoma

Durvalumab Granted Priority Review by FDA for Muscle-Invasive Bladder Cancer Treatment
AstraZeneca’s durvalumab (IMFINZI) has been granted Priority Review by the US Food and Drug Administration (FDA) for the treatment of patients with muscle-invasive bladder cancer (MIBC). This decision is based on data from the phase 3 NIAGARA trial, which demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and overall survival (OS) for patients receiving perioperative durvalumab in combination with standard therapies. FDA approval would make durvalumab the only perioperative immunotherapy regimen available in the curative-intent setting. ...
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