News Report · Oncology

FDA Approves Durvalumab for NMIBC: 32% DFS Improvement in POTOMAC Trial

June 09, 2026

Clinical Perspective

The approval of durvalumab in combination with BCG represents a significant advancement in the treatment of high-risk NMIBC, providing clinicians with a new therapeutic option that enhances disease-free survival outcomes.

Dr. Meera Pillai · Oncology

Durvalumab (Imfinzi) reduced disease-free survival (DFS) by 32% versus Bacillus Calmette-Guerin (BCG) in patients with high-risk non-muscle invasive bladder cancer (NMIBC) in the POTOMAC trial (HR 0.68; 95% CI 0.50-0.93) ^[1].

Clinical Context

Non-muscle invasive bladder cancer (NMIBC) is a significant health concern, characterized by tumors that do not invade the muscle layer of the bladder. This condition affects a substantial number of adults, with high-risk features including T1 tumors, high-grade tumors, carcinoma in situ (CIS), or multiple and recurrent tumors. Current treatment primarily involves intravesical Bacillus Calmette-Guerin (BCG) therapy, which has been the standard of care for NMIBC. However, many patients experience recurrence or progression, highlighting a critical gap in effective treatment options. The recent approval of durvalumab in combination with BCG aims to address this gap by providing a novel immunotherapy approach for BCG-naïve patients with high-risk NMIBC.

Key Findings

The POTOMAC trial showed durvalumab reduced DFS by 32% versus BCG induction and maintenance alone (HR 0.68; 95% CI 0.50-0.93) ^[1].
The trial enrolled 1,018 adult patients with high-risk NMIBC following transurethral resection of bladder tumor ^[1].
Event rates: 40% for durvalumab plus BCG versus 57% for BCG alone ^[1].
The primary endpoint was investigator-assessed disease-free survival (DFS) ^[1].
Secondary results indicated improved outcomes for patients receiving durvalumab in terms of recurrence rates ^[1].
Durvalumab is administered at a dose of 1,500 mg every four weeks for 13 cycles in combination with BCG induction and maintenance treatment ^[1].
Clinicians should consult current prescribing information for full dosing guidance.

Safety & Tolerability

Immune-mediated adverse reactions reported with durvalumab — monitor during treatment ^[1].
Infusion-related reactions reported — exact frequency not available in public source summary ^[1].
Complications of allogeneic hematopoietic stem cell transplantation reported ^[1].
Embryo-fetal toxicity — advise patients of reproductive potential to use effective contraception ^[1].
Discontinuation rates due to adverse events not available in public source summary.
Complete adverse event profile available in the full prescribing information for durvalumab (Imfinzi) ^[1].

What This Means for Clinical Practice

Durvalumab is indicated for adults with BCG-naïve, high-risk NMIBC as part of a combination therapy with BCG. The data supports a 32% improvement in DFS with this regimen compared to BCG alone. What additional long-term benefits might emerge from this combination therapy in terms of overall survival?

Study Design

The POTOMAC trial was a randomized, open-label, multicenter study that enrolled 1,018 patients with high-risk NMIBC. The primary endpoint was disease-free survival (DFS), defined as the time from randomization until the first recurrence of high-risk NMIBC, persistent CIS, muscle-invasive bladder cancer, metastatic disease, or death. Patients were randomized in a 1:1:1 ratio to receive either durvalumab plus BCG, BCG alone, or an additional investigational regimen. The follow-up duration was sufficient to assess the primary endpoint, with results indicating a statistically significant improvement in DFS with the durvalumab and BCG combination.

FAQ

What is durvalumab (Imfinzi) approved for?

Durvalumab (Imfinzi) is approved for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC) as of May 28, 2026, based on the POTOMAC trial showing a 32% improvement in disease-free survival compared to BCG alone.

How does durvalumab work?

Durvalumab is an anti-PD-L1 immunotherapy that enhances the immune response against cancer cells by blocking the interaction between PD-L1 on tumor cells and PD-1 on T cells, thereby promoting T cell activation and proliferation.

What is the recommended dose of durvalumab?

The recommended dose of durvalumab is 1,500 mg administered intravenously every four weeks for 13 cycles in combination with BCG induction and maintenance treatment. Clinicians should consult current prescribing information for full dosing guidance.

What are the most common side effects of durvalumab?

Common side effects include immune-mediated adverse reactions, infusion-related reactions, and complications related to allogeneic hematopoietic stem cell transplantation. The exact frequency of these events is not detailed in the public source summary.

How does durvalumab compare to BCG?

In the POTOMAC trial, durvalumab in combination with BCG demonstrated a 32% reduction in disease-free survival compared to BCG alone, indicating a significant improvement in outcomes for patients with high-risk NMIBC.

Who qualifies for durvalumab treatment?

Patients eligible for durvalumab treatment include adults with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC) as defined by specific tumor characteristics such as T1 tumors, high-grade tumors, or multiple recurrent tumors.

References

FDA — FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer.

FDA Approves Durvalumab for NMIBC: 32% DFS Improvement in POTOMAC Trial

FDA Approves Durvalumab for NMIBC: 32% DFS Improvement in POTOMAC Trial

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

What This Means for Clinical Practice

Study Design

FAQ

References

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