News | July 31, 2025
Imfinzi granted Priority Review and Breakthrough Therapy Designation in US
For patients with resectable early-stage gastric and gastroesophageal junction cancers
For patients with resectable early-stage gastric and gastroesophageal junction cancers
Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
Imfinzi reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone
Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone
Imfinzi also recommended for patients with mismatch repair deficient disease
First immunotherapy regimen before and after surgery to extend survival in bladder cancer
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
Longest survival follow-up ever reported for immunotherapy treatment in this setting
First and only immunotherapy to demonstrate survival benefit in this setting in a global Phase III trial
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