ImmunityBio Moves Closer To EU Approval For Bladder Cancer Therapy

Core Viewpoint - The European Medicines Agency (EMA) has recommended conditional marketing authorization for ImmunityBio's Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [1][4]. Group 1: Clinical Trial Results - A single-arm clinical trial involving 100 adults showed a complete response rate of 71%, with responses lasting up to 54+ months and an average duration of approximately 27 months [2]. - The complete response rates at 12 months and 24 months were 66% and 42%, respectively [3]. Group 2: Regulatory and Market Context - The conditional marketing authorization is part of an EU regulatory mechanism aimed at providing early access to medicines for unmet medical needs [4]. - Bladder cancer is the fifth-most common cancer and the seventh most frequently diagnosed cancer in men, with an estimated 200,000 new cases expected in 2025 [4]. - Approximately 75% of these patients (150,000) will have NMIBC, which is the most common form of bladder cancer [5]. Group 3: Next Steps and Market Reaction - ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy results to the EMA post-marketing [3]. - Following the EMA's recommendation, the opinion will be forwarded to the European Commission for final approval of EU-wide marketing authorization [6]. - ImmunityBio's shares increased by 2.74% to $2.25 at the time of publication [6].