Nogapendekin alfa inbakicept receives EU authorization for BCG-unresponsive NMIBC

The European Commission has granted conditional marketing authorization to nogapendekin alfa inbakicept (Anktiva) in combination with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, ImmunityBio announced.¹

The conditional authorization pathway is used when the benefits of an agent’s immediate availability to patients outweighs the risks associated with needing additional data for full approval. The conditional marketing authorization is subject to annual renewal.

This authorization enables commercial availability of nogapendekin alfa inbakicept across all 27 EU member states as well as Iceland, Norway, and Liechtenstein. The decision adds on to previous approvals of the agent in the US (April 2024), United Kingdom (July 2025), and the Kingdom of Saudi Arabia (January 2026).

“The European Commission’s authorization of Anktiva in combination with BCG marks a defining moment for patients with BCG-unresponsive NMIBC CIS across Europe, who until now have had no authorized treatment and faced radical cystectomy as their only alternative,” said Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, in the news release.¹ “With Anktiva now authorized in 33 countries from the United States and United Kingdom to the European Union and Saudi Arabia, we have built the broadest global access platform for an immunotherapy in this indication.”

The authorization of nogapendekin alfa inbakicept is supported by data from the phase 2/3 QUILT-3.032 study (NCT03022825), which included 100 adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors.² Participants in the study received nogapendekin alfa inbakicept plus intravesical BCG.

Overall, the trial demonstrated a complete response rate of 71% (95% CI, 61 to 80), with responses ranging up to 54 months and ongoing. The average duration of response was 26.6 months (95% CI, 13 to 49.9). The disease-specific survival was 99% at both 24 months and 36 months.

Among those who responded to treatment, the complete response rate was 66% at 12 months and 42% at 24 months. The cystectomy-free survival among responders was 96% at 12 months, 90% at 24 months, and 84% at 36 months.

The investigators also conducted a safety analysis comprised of patients in cohorts A and B in the trial (n = 180). The majority of treatment-related adverse events (TRAEs) were grade 1 to 2, with 3% of patients experiencing a grade 3 TRAE. No grade 4 or 5 TRAEs were reported. The most common AEs included dysuria, hematuria, pollakiuria, urinary tract infection, micturition urgency, fatigue, chills, musculoskeletal pain, and pyrexia.

As part of the conditional authorization agreement, ImmunityBio will continue to submit long-term safety and efficacy data from the trial to the European Medicines Agency.

Soon-Shiong concluded in the news release,¹ “With more than 80% of treated patients preserving their bladder through 3 years of follow-up, Anktiva represents a meaningful advance designed to strengthen the immune response and extend the durability of BCG.”

REFERENCES

1. ImmunityBio receives authorization from the European Commission for ANKTIVA® with BCG for non-muscle invasive bladder cancer carcinoma in situ, expanding global access to 33 countries. News release. February 18, 2026. Accessed February 18, 2026. https://www.businesswire.com/news/home/20260218759994/en/ImmunityBio-Receives-Authorization-from-the-European-Commission-for-ANKTIVA-with-BCG-for-Non-Muscle-Invasive-Bladder-Cancer-Carcinoma-in-Situ-Expanding-Global-Access-to-33-Countries

2. Chang SS, Chamie K, Kramolowsky E, et al. An update on QUILT-3.032: Complete responses to N-803 plus BCG therapy in BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease. J Urol. 2025;213(5S):e392. doi:10.1097/01.JU.0001109848.08748.9e.12