← Back to The Docket MAY 28 2026
APPROVED · 64 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
High-risk non-muscle-invasive bladder cancer is an early-stage but aggressive form of the disease where abnormal cells grow in the bladder lining and can spread. Imfinzi is an antibody that helps the body's immune system recognize and attack cancer cells. By adding this immune boost to the standard BCG therapy, the combination may more effectively eliminate these early tumors and prevent the cancer from returning.
Pivotal trial
POTOMAC Phase 3 active not recruiting NCT03528694 This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer
Source: ClinicalTrials.gov