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# Imfinzi Get Expanded Use in High-Risk Bladder Cancer
- URL: https://www.fdaweb.com/imfinzi-get-expanded-use-in-high-risk-bladder-cancer/
- Published: 2026-05-28T12:00:00.000Z
- Updated: 2026-09-14T13:40:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161221

FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-naïve, high-risk non-muscle invasive bladder cancer, expanding the use of the company’s immunotherapy. The approval covers patients with high-risk non-muscle invasive bladder cancer, or NMIBC, following transurethral resection of a bladder tumor.

The approval was based on results from the Phase 3 POTOMAC trial, which enrolled 1,018 patients with high-risk NMIBC. Eligible patients had at least one high-risk feature, including T1 tumors, high-grade disease, carcinoma in situ or multiple recurrent large tumors, according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder?ref=fdaweb.com).

The main endpoint was disease-free survival, defined as the time until recurrence of high-risk NMIBC, persistent carcinoma in situ, progression to muscle-invasive or metastatic disease, or death. According to FDA, patients treated with durvalumab plus BCG demonstrated a statistically significant improvement in disease-free survival compared with BCG alone. The combination reduced the risk of recurrence or progression by 32%. Median disease-free survival had not yet been reached in either treatment arm at the time of analysis.

Durvalumab is a programmed death ligand-1, or PD-L1, blocking antibody already approved for several cancer indications, including lung and liver cancers. The prescribing information for Imfinzi includes warnings about immune-mediated adverse reactions, infusion-related reactions, complications following allogeneic hematopoietic stem cell transplantation and embryo-fetal toxicity.