LONDON (dpa-AFX) - AstraZeneca (AZN) has secured U.S. Food and Drug Administration approval for its immunotherapy IMFINZI (durvalumab) in combination with enfortumab vedotin-ejfv as a perioperative treatment for adult patients with muscle-invasive bladder cancer or MIBC who are ineligible for, or have declined, cisplatin-based chemotherapy.
The newly approved regimen consists of neoadjuvant treatment with IMFINZI and enfortumab vedotin-ejfv prior to radical cystectomy, followed by adjuvant IMFINZI monotherapy after surgery. The approval provides a new treatment option for patients with MIBC who previously had limited alternatives when cisplatin-based chemotherapy was not suitable.
The FDA granted approval following a Priority Review based on positive findings from the Phase III VOLGA trial. Results from the study demonstrated that the treatment combination significantly improved patient outcomes, reducing the risk of disease recurrence by 49% and lowering the risk of death by 42% compared with standard treatment approaches. The regimen also showed a manageable safety profile consistent with the known profiles of the individual therapies, the company said.
Muscle-invasive bladder cancer is an aggressive form of the disease associated with a high risk of recurrence and mortality even after surgery. Perioperative treatment strategies aim to reduce the likelihood of disease progression and improve long-term survival outcomes.
Beyond the United States, AstraZeneca is pursuing additional regulatory approvals for the regimen. Applications supported by the VOLGA Phase III data are currently under review in the European Union, Japan and several other markets, potentially expanding access to the treatment for eligible patients worldwide.
IMFINZI is approved in over 50 countries for patients with cisplatin-eligible MIBC based on the NIAGARA Phase III trial. IMFINZI in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy is approved in the US, Japan and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer, based on the POTOMAC Phase III trial.
In July 2026, positive high-level results from the NILE Phase III trial showed IMFINZI plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.
AZN closed Friday's regular trading at $184.45 up $0.07 or 0.04%.
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