← Back to The Docket MAY 28 2026
APPROVED · 124 DAYS AGO
— Imfinzi (durvalumab)
$AZN
for BCG-naïve, high-risk non-muscle-invasive bladder cancer
BLA
FDA approved AstraZeneca's Imfinzi in combination with BCG induction and maintenance therapy for BCG-naïve, high-risk non-muscle-invasive bladder cancer.
About
Imfinzi is an antibody that helps the immune system recognize and attack cancer cells. In high-risk bladder cancer, abnormal cells grow inside the bladder and can spread if not controlled. By boosting the body's natural defenses, this drug could help eliminate these cancer cells before they cause more serious harm.
Pivotal trial
PATAPSCO Phase 3 active not recruiting NCT05943106 The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior systemic therapy for NMIBC, and who are BCG-naïve.
Source: ClinicalTrials.gov