← Back to The Docket MAY 28 2026
APPROVED · 6 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
Bladder cancer occurs when abnormal cells grow uncontrollably in the bladder, often leading to tumors that can spread and damage surrounding tissues. Imfinzi (durvalumab) is an antibody that helps the immune system recognize and attack cancer cells by blocking a protein that tumors use to evade detection. By enhancing the body’s natural defenses, Imfinzi may help prevent the progression of early-stage bladder cancer in patients who haven’t received prior BCG therapy.
Pivotal trial
ARCADIA Phase 2 unknown NCT03824691 Cabozantinib plus Durvalumab in patients with advanced and chemotherapy-treated bladder carcinoma, of urothelial and non-urothelial histology: an open-label, single-centre, phase 2, single-arm proof-of-concept trial: ARCADIA study
Source: ClinicalTrials.gov