Durvalumab Plus BCG Earns FDA Nod for Bladder Cancer
The FDA has approved durvalumab in combination with BCG for high-risk non-muscle-invasive bladder cancer. This decision is based on the results of the POTOMAC study, which showed improved disease-free survival for patients receiving the combination treatment. The recommended dosage for durvalumab is 1500 mg every four weeks, alongside BCG induction and maintenance.
- ▪Durvalumab has been approved by the FDA for use with BCG in treating high-risk non-muscle-invasive bladder cancer.
- ▪The approval is based on the POTOMAC study involving 1018 patients.
- ▪Patients receiving durvalumab plus BCG showed significantly improved disease-free survival compared to those receiving BCG alone.
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| Original publisher | Medscape |
| Canonical URL | https://www.medscape.com/viewarticle/durvalumab-plus-bcg-earns-fda-nod-bladder-cancer-2026a1000hv5?src=rss |
| Publication time | Thu, 28 May 2026 16:20:48 EDT |
| Retrieval time | 2026-05-28T20:29:37.587Z |
| Last seen | 2026-05-28T20:29:37.587Z |
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| Publisher visit | Yes — open original |
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| Retrieval / RAG | May the content be exposed for third-party retrieval-augmented generation? | Not asserted |
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| Commercial reuse | May the content be reused commercially? | Not permitted |
Basis: Derived from the published RSS/Atom feed. Contact: [email protected]. Reviewed: 2026-07-24.
Opening excerpt (first ~120 words) tap to expand
The FDA has approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NIMBC).Approval was based on findings from the randomized, open-label POTOMAC study of 1018 patients with high-risk NIMBC who had undergone transurethral bladder tumor resection, according to the FDA approval notice. Patients who were randomized to durvalumab every 4 weeks for 13 cycles plus BCG induction and maintenance experienced significantly improved disease-free survival (DFS) vs those randomized to BCG induction and maintenance alone (hazard ratio, 0.68).
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Excerpt limited to ~120 words for fair-use compliance. The full article is at Medscape.
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