USFDAMay 29, 2026, 06:51 AM
AstraZeneca Imfinzi approved in US for early bladder cancer
AI Summary
AstraZeneca's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) has received US FDA approval for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This approval, based on the positive results from the POTOMAC Phase III trial, marks the first immunotherapy combination regimen for this patient population in over 30 years. The trial demonstrated a 32% reduction in the risk of high-risk disease recurrence, progression, or death, offering a significant advancement in treatment options.
Key Highlights
- AstraZeneca's Imfinzi (durvalumab) in combination with BCG approved in the US for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).
- Approval is based on positive results from the POTOMAC Phase III trial.
- POTOMAC trial showed a 32% reduction in the risk of high-risk disease recurrence, progression, or death.
- This is the first immunotherapy combination regimen approved for this patient population in over 30 years.
- Regulatory submissions based on POTOMAC results are also under review in the EU, Japan, and other countries.
- Recently announced positive high-level results from VOLGA Phase III trial for Imfinzi in muscle-invasive bladder cancer (MIBC).
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