TOC
【FDA Approval Alert】AstraZeneca’s durvalumab (Imfinzi) Approved for Muscle-Invasive Bladder Cancer (March 28, 2025)
On March 28, 2025, the U.S. FDA approved durvalumab (Imfinzi) for adult patients with muscle-invasive bladder cancer (MIBC) as neoadjuvant therapy combined with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy after radical cystectomy. Approval was based on the NIAGARA trial (NCT03732677).
Disease Overview: Muscle-Invasive Bladder Cancer (MIBC)
MIBC is an advanced form of bladder cancer where the tumor invades the bladder muscle layer. Radical cystectomy is standard treatment, and perioperative systemic therapies improve outcomes.
Treatment Summary
- Drug Name: durvalumab (Imfinzi)
- Company: AstraZeneca Pharmaceuticals LP
- Approval Date: March 28, 2025
- Indication: Neoadjuvant + adjuvant therapy for MIBC
- Mechanism of Action: Anti-PD-L1 antibody (immune checkpoint inhibitor)
- Pivotal Trial: NIAGARA (NCT03732677)
- Key Efficacy:
- Event-Free Survival (EFS): Median not reached vs 46.1 months (HR 0.68; p<0.0001)
- Overall Survival (OS): HR 0.75; p=0.0106
Patient-Friendly Summary
Imfinzi added before and after surgery helps reduce recurrence risk for patients undergoing radical cystectomy for muscle-invasive bladder cancer.
M&A Information
- Subsidiary: Not applicable (AstraZeneca in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (LSE: AZN)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
