AstraZeneca's Imfinzi approved in EU for muscle-invasive bladder cancer, showing positive results.

AstraZeneca’s Imfinzi receives EU approval for treating muscle-invasive bladder cancer 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 showing a 32% reduction in recurrence risk and a 25% reduction in mortality compared to neoadjuvant chemotherapy alone. Imfinzi is also approved in the US and other countries for similar indications based on NIAGARA results, with regulatory applications under review in Japan and other countries. Imfinzi is approved in other settings for lung cancer based on Phase III trials.

Read more at Nasdaq: AstraZeneca’s Imfinzi Approved In EU For Muscle-Invasive Bladder Cancer