LONDON (dpa-AFX) - British drug major AstraZeneca Plc. (AZN.L, AZN) announced Friday that Imfinzi (durvalumab) has been approved in the European Union for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical?cystectomy.
The approval is based on NIAGARA Phase III trial results, which demonstrated a 32% reduction in recurrence risk and a 25% reduction in mortality for the Imfinzi regimen compared to neoadjuvant chemotherapy alone.
Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. Regulatory applications for this indication are currently under review in Japan and several other countries. Imfinzi is also approved in other curative-intent settings based on the PACIFIC and AEGEAN Phase III trials in non-small cell lung cancer (NSCLC), and in limited-stage small cell lung cancer (SCLC) based on the ADRIATIC Phase III trial.
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