EMA Recommends Conditional Approval for ImmunityBio's Anktiva in BCG-Unresponsive Bladder Cancer
核心洞察
The European Medicines Agency (搜索) has recommended conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept) combined with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
Clinical trial data showed a 71% complete response rate in 100 patients, with responses lasting an average of 27 months and ranging up to 54+ months.
The conditional approval pathway facilitates early access to medicines addressing unmet medical needs, with the decision now moving to the European Commission for final authorization.
The European Medicines Agency (搜索) (EMA) has recommended granting conditional marketing authorization for ImmunityBio's Anktiva (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. The decision represents a significant step toward providing European patients with a new treatment option for this challenging condition.
Clinical Trial Results Drive Regulatory Decision
The EMA's recommendation was based on results from a single-arm clinical trial (NCT03022825) involving 100 adult patients with BCG-unresponsive NMIBC carcinoma in situ with or without papillary disease. The trial demonstrated a complete response rate of 71% (95% CI, 61.1 to 79.6), with responses ranging up to more than 54 months and lasting an average of 27 months.
Among patients who responded to treatment, the complete response rate was 66% at 12 months and 42% at 24 months, indicating sustained therapeutic benefit over time.
Conditional Approval Pathway Enables Early Access
The conditional marketing authorization represents an EU regulatory mechanism designed to facilitate early access to medicines addressing unmet medical needs. According to the EMA, this pathway allows for marketing authorization when the benefits of immediate patient access outweigh potential risks associated with data from a single-arm trial.
"ANKTIVA represents an important evolution in the treatment of NMIBC CIS, strengthening the immune response and improving the durability of BCG," said Patrick Soon-Shiong, MD, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "Hundreds of patients in the US are already experiencing the benefits of this therapy, and our goal is to make it available to patients in Europe and other parts of the world as quickly and responsibly as possible, to ensure avoidance of a radical cystectomy."
Addressing Significant Disease Burden
Bladder cancer ranks as the fifth-most common cancer and the seventh most frequently diagnosed cancer in men. The European Association of Urology and World Bladder Cancer Patient Coalition estimate that more than 200,000 patients will be diagnosed with bladder cancer in 2025. Approximately 75% of these patients (150,000) will have NMIBC, which is cancer that has grown only on the lining of the bladder and not into the muscle layer underneath.
European Market Advantages
Unlike the United States, where only one substrain of BCG is available, Europe has access to six approved substrains. "Six BCG strains are available in Europe for use in combination with ANKTIVA, and we are expeditiously developing our recombinant BCG candidate to address ongoing BCG shortages in the US and help ensure that all eligible patients can benefit from this treatment," said Richard Adcock, President and CEO of ImmunityBio.
Next Steps and Market Considerations
The EMA's opinion will now be forwarded to the European Commission for final approval of EU-wide marketing authorization. As part of the conditional approval recommendation, ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy post-marketing results to the EMA.
Anktiva was previously approved in the United States in April 2024 and in the United Kingdom in July 2025 for this indication. "With the United States' new Most-Favored-Nation Prescription Drug Pricing policy now in effect, we are thoughtfully assessing our approach to launching in Europe to ensure broad, equitable, and sustainable access," concluded Adcock.