FDA approves durvalumab for muscle invasive bladder cancer

Regulatory approval: On March 28, 2025, the FDA approved durvalumab (Imfinzi) in combination with gemcitabine and cisplatin as neoadjuvant therapy, followed by single-agent durvalumab as adjuvant therapy after radical cystectomy, for adults with muscle invasive bladder cancer. Approval was supported by the phase III NIAGARA trial (NCT03732677), which showed statistically significant improvements in event-free survival and overall survival versus neoadjuvant chemotherapy followed by surgery alone.

FDA approval (March 28, 2025)

The US Food and Drug Administration (FDA) approved durvalumab (Imfinzi; AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).

Supporting evidence

Efficacy and safety were evaluated in NIAGARA (NCT03732677), a randomized, open-label, multicenter, phase III trial (n=1,063) in patients eligible for radical cystectomy with no prior systemic therapy for bladder cancer. Patients were randomized 1:1 to:

  • Neoadjuvant durvalumab + chemotherapy, then adjuvant durvalumab after surgery, or
  • Neoadjuvant chemotherapy, then surgery alone.

The major efficacy endpoint was event-free survival (EFS) by blinded independent central review; overall survival (OS) was an additional endpoint. At a pre-specified interim analysis, the trial showed statistically significant improvements in EFS and OS:

  • EFS: median not reached vs 46.1 months; HR 0.68 (95% CI 0.56–0.82); p<0.0001
  • OS: median not reached in both arms; HR 0.75 (95% CI 0.59–0.93); p=0.0106

Adverse reactions were reported as consistent with prior experience with durvalumab plus platinum-based chemotherapy.

Dosing (label)

For body weight ≥30 kg: 1,500 mg q3w with chemotherapy (neoadjuvant) and 1,500 mg q4w as monotherapy (adjuvant). For <30 kg: 20 mg/kg on the same schedules. Treatment continues until progression precluding definitive surgery, recurrence, unacceptable toxicity, or a maximum of 8 post-surgery cycles.

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