LONDON (dpa-AFX) - British drug major AstraZeneca Plc. (AZN.L, AZN) announced Tuesday that its Imfinzi (durvalumab) has been recommended for approval in the European Union to treat muscle-invasive bladder cancer or MIBC.
The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency made the recommendation for the treatment of adult patients with resectable MIBC in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder).
Imfinzi has been recommended for approval in the EU as first and only perioperative immunotherapy for MIBC.
The recommendation is 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.
The trial results were presented during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress and in The New England Journal of Medicine.
The company noted that in a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm.
Results from the key secondary endpoint of overall survival showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy alone.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said, 'The Imfinzi-based perioperative regimen in the NIAGARA Phase III trial enabled survival of more than 80 per cent of patients at two years after treatment. This supports our strategy of moving our innovative medicines into the earlier stages of disease where the opportunity for treatment with curative intent is greatest. If approved, this novel approach will become a much-needed new treatment option for patients in Europe and could become the new standard of care in this setting.'
Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. Regulatory applications are currently under review in Japan and several other countries.
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