Company: AZN
Filing Date: 2025-03-31
Form Type: 6-K
Source: 0001654954-25-003589
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-03-31
Form: 6-K
Chunk 1
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 by the Food and Drug Administration (FDA) after securing Priority Review and was based on results from the NIAGARA Phase III trial which were presented during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine .

In 2024, over 20,000 people in the US were treated for MIBC. 1 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases. 2 This represents a curative-intent setting, where the current standard of care is neoadjuvant chemotherapy and radical cystectomy. 3 However, even after surgery, patients experience high rates of disease recurrence and have a poor prognosis. 3

Matthew ND. Galsky, Lillian and Howard Stratton Professor of Medicine, Director of Genitourinary Medical Oncology, The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, New York, and NIAGARA investigator and steering committee member, said: "This approval for the durvalumab-based perioperative regimen is a major breakthrough for people with muscle-invasive bladder cancer, nearly half of whom see their cancer return despite chemotherapy and surgery with curative-intent. This durvalumab regimen significantly extended patients' lives in the NIAGARA trial and has the potential to transform care."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Today's approval for Imfinzi represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with muscle-invasive bladder cancer and addressing a significant need for better treatment options. The NIAGARA trial showed more than 80 per cent of patients were still alive at two years, underscoring the potential of this innovative perioperative regimen to become a new standard of care in this setting."

Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, said: "More than 20,000 people in the US were treated for muscle-invasive bladder cancer last year and there is a significant need for new treatment options that improve patient outcomes. The approval of the durvalumab perioperative regimen is welcome news, transforming how clinicians will tackle this disease in future and offering new hope to patients and their loved ones."

In the trial, patients were treated with four cycles of Imfinzi in combination with neoadjuvant