FDA Approves Durvalumab and BCG for High-Risk NMIBC

Key Takeaways

• On March 28, 2025, FDA approved durvalumab with gemcitabine and cisplatin as neoadjuvant therapy, then adjuvant durvalumab after radical cystectomy, for adults with muscle-invasive bladder cancer (MIBC).
• Efficacy came from NIAGARA (NCT03732677), a Phase 3 trial of 1,063 patients, with EFS HR 0.68 and OS HR 0.75 versus neoadjuvant chemotherapy alone.
• FDA did not approve durvalumab plus BCG for high-risk NMIBC in the cited oncology approval notices.
• For BCG-unresponsive NMIBC with CIS, FDA approved Anktiva (nogapendekin alfa inbakicept-pmln) with BCG on April 22, 2024.

What did FDA actually approve for durvalumab in bladder cancer?

FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with muscle-invasive bladder cancer as neoadjuvant treatment with gemcitabine and cisplatin, followed by single-agent adjuvant durvalumab after radical cystectomy. Recommended dosing for patients ≥30 kg is 1,500 mg every 3 weeks with chemotherapy neoadjuvantly and 1,500 mg every 4 weeks as adjuvant monotherapy (weight-based dosing applies below 30 kg).

This is a peri-operative MIBC regimen, not an intravesical BCG combination for NMIBC.

Primary: FDA durvalumab MIBC approval page (March 28, 2025).

What did NIAGARA show?

NIAGARA (NCT03732677) was a randomized, open-label, multicenter Phase 3 trial of 1,063 cystectomy-eligible patients without prior systemic therapy for bladder cancer. Patients were randomized 1:1 to neoadjuvant durvalumab plus chemotherapy then adjuvant durvalumab, or neoadjuvant chemotherapy then surgery alone.

At a pre-specified interim analysis, median EFS was not reached in the durvalumab arm versus 46.1 months in the chemotherapy arm (HR 0.68; 95% CI 0.56–0.82; p<0.0001). Median OS was not reached in either arm (HR 0.75; 95% CI 0.59–0.93; p=0.0106).

Registry: ClinicalTrials.gov NCT03732677.

Which BCG combination is approved for high-risk NMIBC?

On April 22, 2024, FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) with BCG for adult patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors. That is the labeled BCG combination in this setting — distinct from durvalumab. Other NMIBC options on FDA oncology approval lists include pembrolizumab monotherapy in BCG-unresponsive disease and later 2025 approvals such as gemcitabine intravesical system (Inlexzo) for BCG-unresponsive NMIBC with CIS.

Primary list entry context: FDA oncology approval notifications.

Why the correction matters for investors and CI

Mislabeling MIBC as NMIBC, or swapping Anktiva’s BCG combo for durvalumab, breaks competitive maps and revenue models. Durvalumab’s 2025 bladder expansion is a peri-operative systemic checkpoint inhibitor story tied to NIAGARA. NMIBC BCG-unresponsive algorithms remain a different commercial and clinical channel.

• Drug: durvalumab (Imfinzi)
• Correct 2025 bladder approval setting: MIBC peri-operative
• Pivotal trial: NIAGARA / NCT03732677 / n=1,063
• EFS HR 0.68; OS HR 0.75
• NMIBC+BCG approved combo example: Anktiva (April 22, 2024)

What remains unproven

This article does not claim a durvalumab-plus-BCG NMIBC approval. Any future NMIBC development for durvalumab would need its own FDA action. Until then, delete that claim from diligence memos.

Related NovaPharma coverage

• FDA atezolizumab MIBC approval
• AstraZeneca Imfinzi bladder cancer coverage
• Bladder cancer care education

Frequently Asked Questions

Primary Sources

1. FDA: durvalumab MIBC approval
2. ClinicalTrials.gov NCT03732677 (NIAGARA)
3. FDA oncology approval notifications