LONDON (dpa-AFX) - British drug major AstraZeneca Plc.'s (AZN, AZN.L) 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 US for the treatment of adult patients with muscle-invasive bladder cancer (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. The results showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death compared to neoadjuvant chemotherapy alone.
Imfinzi is also approved in Brazil in the setting based on the NIAGARA results. Regulatory applications are currently under review in the EU, Japan and several other countries.
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