Drug Update · Oncology

FDA Approves durvalumab for BCG‑naïve NMIBC: DFS HR 0.68 in POTOMAC

September 06, 2026

FDA approval date

May 28, 2026

Approved indication

BCG‑naïve, high‑risk non‑muscle‑invasive bladder cancer (NMIBC)

Pivotal trial

POTOMAC (NCT03528694)

Trial enrollment

1,018 patients

Primary endpoint result

DFS HR 0.68; 95% CI: 0.50-0.93; p=0.0154

Recommended dose (≥30 kg)

1,500 mg every 4 weeks for 13 cycles in combination with BCG

Clinical Perspective

Clinicians who treat adults with BCG‑naïve, high‑risk NMIBC will now have an FDA‑approved systemic immunotherapy option in combination with BCG, as specified in the Imfinzi prescribing information. The POTOMAC data showing improved investigator‑assessed DFS versus BCG alone support use of durvalumab plus BCG induction and maintenance for these patients. Will durvalumab plus BCG improve long‑term overall survival or change bladder‑preserving strategies in this population?

Dr. Rahul Verma, MBBS, MD (General Medicine), DM (Medical Oncology) · Oncology

On May 28, 2026 the Food and Drug Administration approved durvalumab (Imfinzi) in combination with Bacillus Calmette‑Guérin (BCG) for the treatment of adult patients with BCG‑naïve, high‑risk non‑muscle‑invasive bladder cancer (NMIBC) based on the POTOMAC study showing improved investigator‑assessed disease‑free survival (DFS) versus BCG alone (HR 0.68; 95% CI: 0.50-0.93) ^[3]. The approval is effective as of May 28, 2026 and prescribing information reflecting the new indication will be posted on Drugs@FDA and has an updated label effective date of 2026-05-28 ^[2]^[4].

Clinical Context

Durvalumab (Imfinzi) is a programmed death‑ligand 1 (PD‑L1) blocking monoclonal antibody marketed by AstraZeneca ^[1]^[4]. Prior FDA indications for durvalumab cover several solid tumor settings; the new approval adds an indication in combination with BCG for adult patients with BCG‑naïve, high‑risk NMIBC ^[1]^[2]^[4]. The POTOMAC trial, a randomized, open‑label, multicenter phase 3 study, provided the efficacy evidence supporting the approval and evaluated investigator‑assessed DFS following transurethral resection of bladder tumor (TURBT) and BCG induction and maintenance ^[3]. The label specifies recommended dosing and administration for the approved NMIBC indication ^[4].

Key Findings

The POTOMAC study showed durvalumab plus BCG reduced the risk of disease recurrence, persistent carcinoma in situ (CIS), progression to muscle‑invasive disease, metastatic disease, or death versus BCG induction and maintenance alone (HR 0.68; 95% CI: 0.50-0.93) ^[3].
The trial enrolled 1,018 patients with high‑risk NMIBC after TURBT; high‑risk features were defined as T1 tumor, Grade 3/high‑grade tumor, carcinoma in situ (CIS), or multiple, recurrent, and large tumors ^[3].
Median DFS was not reached for either the durvalumab plus BCG arm or the BCG arm at the analysis reported by the FDA ^[3].

Safety & Tolerability

The prescribing information includes warnings and precautions for immune‑mediated adverse reactions [immune‑mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, nephritis/renal dysfunction, organ transplant rejection, and pancreatitis], infusion‑related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo‑fetal toxicities ^[1]^[4].
The FDA press release and labeling direct clinicians to the full prescribing information for a complete description of adverse reactions and management recommendations ^[3]^[4].

Study Design

The approval was based on POTOMAC, a randomized, open‑label, multicenter phase 3 trial (POTOMAC; NCT03528694) that enrolled 1,018 patients with high‑risk NMIBC after TURBT and randomized patients 1:1:1 to receive durvalumab every 4 weeks for 13 cycles plus BCG induction and maintenance, BCG induction and maintenance alone, or an additional investigational combination regimen; the major efficacy outcome measure was investigator‑assessed disease‑free survival (DFS) ^[3]. Clinicians should consult current prescribing information for full dosing guidance. The FDA completed review of the supplemental biologics license application (sBLA) and issued a prior approval letter effective May 28, 2026 ^[2]^[3].

FAQ

Q1 What is durvalumab (Imfinzi) approved for?

Durvalumab (Imfinzi) is approved in combination with Bacillus Calmette‑Guérin (BCG) for the treatment of adult patients with BCG‑naïve, high‑risk non‑muscle‑invasive bladder cancer (NMIBC). The approval was granted by the FDA on May 28, 2026, and applies to patients who meet the high‑risk NMIBC definition used in the POTOMAC trial.

Q2 How does durvalumab work?

Durvalumab is a human monoclonal antibody that blocks programmed death‑ligand 1 (PD‑L1), inhibiting PD‑L1 interaction with PD‑1 and CD80 (B7.1) and thereby releasing inhibition of immune responses. The mechanism section of the prescribing information describes PD‑L1 blockade leading to increased T‑cell activation.

Q3 What is the recommended dose of durvalumab for this indication?

For patients with body weight ≥30 kg, the recommended durvalumab dose for the NMIBC indication is 1,500 mg administered every 4 weeks for 13 cycles in combination with BCG induction and maintenance. Treatment should continue until recurrence of high‑risk disease, disease progression, unacceptable toxicity, or a maximum of 13 cycles, as specified in the prescribing information.

Q4 What are the most common side effects?

The prescribing information for Imfinzi includes warnings and precautions for immune‑mediated adverse reactions, infusion‑related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo‑fetal toxicities; the full labeling contains more detailed adverse reaction listings by indication and regimen. Specific most‑common adverse reactions for the NMIBC indication were not itemized in the FDA press release; clinicians should consult the full prescribing information for complete adverse reaction data and management guidance.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves durvalumab for BCG‑naïve NMIBC: DFS HR 0.68 in POTOMAC

Direct Clinical Takeaway & Evidence Summary

FDA Approves durvalumab for BCG‑naïve NMIBC: DFS HR 0.68 in POTOMAC

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

Cite & Reference This Monograph

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