AstraZeneca’s Imfinzi wins FDA nod for MIBC

AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the USA for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).

The UK pharma major noted that this makes Imfinzi the first and only perioperative immunotherapy for patients with MIBC.

The approval was granted 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.