WILMINGTON, DE — AstraZeneca‘s IMFINZI® (durvalumab) has gained FDA approval for use in adult patients with muscle-invasive bladder cancer (MIBC), making it the first perioperative immunotherapy available in the U.S. for this condition. The approval is based on results from the NIAGARA Phase III trial, which demonstrated significant improvements in event-free survival (EFS) and overall survival (OS) compared to the standard regimen.
IMFINZI, in combination with gemcitabine and cisplatin as a neoadjuvant treatment before surgery and as a standalone therapy after cystectomy, addresses a critical need in the treatment of MIBC, where high recurrence rates and poor prognoses have been common despite aggressive therapy.
Dr. Matthew ND. Galsky, a lead investigator for NIAGARA, described the approval as a “major breakthrough,” noting the significant extension in survival and reduction in relapse rates for patients on the IMFINZI-based regimen.
The NIAGARA trial highlighted a 32% reduction in risk of disease progression, recurrence, or death with IMFINZI (hazard ratio of 0.68). Additionally, 82.2% of patients treated with the regimen were alive after two years, compared to 75.2% of those in the comparator arm. The therapy was well-tolerated, aligning with IMFINZI’s established safety profile.
“This approval marks a paradigm shift in the treatment of MIBC,” said Dave Fredrickson, Executive Vice President, AstraZeneca Oncology. He added that the results support IMFINZI’s potential to redefine the standard of care in this setting.
The treatment has also been recognized globally, with approval in Brazil and pending regulatory reviews in other countries. For the estimated 20,000 U.S. patients treated for MIBC annually, this advancement offers new hope and a meaningful improvement in outcomes.
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