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(Correcting name of trial, primary endpoint and Dave Fredrickson’s title.) AstraZeneca PLC on Friday said Imfinzi is ‘poised to transform the standard of care’ as it reported the bladder cancer treatment cleared a European regulatory milestone. The Cambridge, England-based pharmaceutical company said Imfinzi has been approved in the EU for treatments in adults with resectable muscle-invasive bladder cancer. The approval is for the use of Imfinzi as a combination treatment, with gemcitabine and cisplatin as neoadjuvant treatment (before surgery), followed by Imfinzi as monotherapy adjuvant treatment. This marks the ‘first and only perioperative immunotherapy for muscle-invasive bladder cancer’, said AstraZeneca. The approval follows the positive opinion put forward by the Committee for Medicinal Products for Human Use, which was based upon the positive results of AstraZeneca’s phase three Niagara trial. This trial showed that Imfinzi, when used as a combination treatment, demonstrated both a statistically significant and clinically meaningful improvement in event-free survival, the trial’s primary endpoint. Over 35,000 individuals were treated with MIBC in the five major European countries last year, noted AstraZeneca, adding that many patients have to face disease reoccurrence following surgery. ‘Imfinzi is poised to transform the standard of care for muscle-invasive bladder cancer in Europe as the first and only perioperative immunotherapy for these patients. In the Niagara Phase III trial, more than 80 per cent of patients were still alive two years after treatment with the Imfinzi regimen, setting a new survival benchmark for a disease that has seen few treatment advances in decades,’ said Dave Fredrickson, executive vice president of the Oncology Haematology business unit at AstraZeneca. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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