FDA Approves AstraZeneca's Imfinzi for Bladder Cancer Treatment

AstraZeneca's drug Imfinzi has received FDA approval as the first immunotherapy for perioperative treatment of muscle-invasive bladder cancer (MIBC), marking a significant advancement in treatment options. The approval is based on the results of the NIAGARA Phase III trial, which demonstrated a 32% reduction in disease progression or death and a 25% decrease in the risk of death compared to chemotherapy alone. Imfinzi will be used in combination with gemcitabine and cisplatin as an initial treatment, followed by monotherapy after radical cystectomy. The approval has been welcomed by advocacy groups highlighting the need for better treatment options. According to AstraZeneca executives, this regimen could redefine the standard of care for MIBC patients. Regulatory applications for Imfinzi are also under review in several other countries, including the EU and Japan.