AstraZeneca's Imfinzi gets EU green light
By Iain Gilbert
Date: Friday 04 Jul 2025
(Sharecast News) - Drugmaker AstraZeneca said on Friday that its Imfinzi asset has been approved in the EU as the first and only perioperative immunotherapy for muscle-invasive bladder cancer.
AZN said the European Commission's approval of Imfinzi was based on positive Phase III trial results, which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death when used in combination with gemcitabine and cisplatin as neoadjuvant treatment, versus neoadjuvant chemotherapy alone.
Dave Fredrickson, executive vice president of AstraZeneca's oncology haematology unit, said: "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."
The FTSE 100-listed group noted that Imfinzi, which has already received US approval, was "generally well tolerated", and no new safety signals were observed in the neoadjuvant and adjuvant settings.
Reporting by Iain Gilbert at Sharecast.com
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