Core Insights - AstraZeneca's Imfinzi has received European Commission approval for treating muscle-invasive bladder cancer (MIBC) in adults, marking a significant milestone for the company [1][6] - The approval is based on the phase III NIAGARA study, which demonstrated a 32% reduction in the risk of disease progression or death with the Imfinzi-based treatment regimen [2][6] - Imfinzi is a key revenue driver for AstraZeneca, generating $1.26 billion in sales in Q1 2025, reflecting a 16% year-over-year increase [6][9] Regulatory Approval - The European Medicines Agency's Committee for Medicinal Products for Human Use had previously recommended approval for Imfinzi in May, leading to the recent EU approval [3] - The FDA also approved Imfinzi for a similar indication in March, with additional regulatory applications under review in Japan and other countries [3] Clinical Study Results - The NIAGARA study showed a 25% reduction in the risk of death for patients treated with the Imfinzi-based regimen compared to the control group [2] - Imfinzi is currently approved for multiple cancer indications, including stage III non-small cell lung cancer (NSCLC) and other advanced cancers [8] Market Performance - Year-to-date, AstraZeneca's shares have increased by 6%, contrasting with a 1.4% decline in the broader industry [4] - Imfinzi's sales growth is primarily driven by demand in lung and liver cancer treatments [6][9]